Obstetrics

Roughly 1%-2% of pregnancies are complicated by an adnexal mass, and prenatal ultrasound for fetal evaluation has detected more asymptomatic ovarian masses as a result.

The differential diagnosis for adnexal mass is broad and includes follicular or corpus luteum cysts, mature teratoma, theca lutein cyst, hydrosalpinx, endometrioma, cystadenoma, pedunculated leiomyoma, luteoma, as well as malignant neoplasms of epithelial, germ cell, and sex cord–stromal origin (J Ultrasound Med. 2004 Jun;23[6]:805-19). Most masses will be benign neoplasms, with a fraction identified as malignancies.

In 2013, Baser et al. performed a retrospective study of 151 women who underwent surgery of an adnexal mass at time of cesarean delivery. Of the 151 cases reviewed, 148 (98%) of the masses were benign (Int J Gynaecol Obstet. 2013 Nov;123[2]:124-6). Additionally, if the patient presents with pain, diagnoses such as ectopic pregnancy, heterotopic pregnancy, degenerating fibroid, and torsion should also be considered.

Diagnostic evaluation and management

The majority of adnexal masses identified in pregnancy are benign simple cysts measuring less than 5 cm in diameter. Approximately 70% of cystic masses detected in the first trimester will spontaneously resolve by the second trimester (Clin Obstet Gynecol. 2006 Sep;49[3]:492-505). However, for some masses, surgical resection is warranted.

Masses present after the first trimester and that are (1) greater than 10cm in diameter or (2) are solid or contain solid and cystic areas or have septated or papillary areas, are generally managed surgically as these features increase the risk of malignancy or complications such as adnexal torsion, rupture, or labor dystocia (Gynecol Oncol. 2006 May;101(2):315-21).

Adnexal masses without these features often resolve during pregnancy and can be expectantly managed (Obstet Gynecol. 2005 May;105[5 Pt 1]:1098-103). The optimal time for surgical intervention is after the first trimester as organogenesis is largely complete, therefore minimizing the risk of drug-induced teratogenesis, and any necessary cystectomy or oophorectomy will not disrupt the required progesterone production of the corpus luteum as this has been replaced by the placenta.

Preoperative assessment

For most cases, imaging with ultrasound is adequate for preoperative evaluation; however, in some cases, further imaging is needed for appropriate characterization of the mass. In this situation, further imaging with MRI is preferred as this modality has good resolution for visualization of soft tissue pathology and does not expose the patient and fetus to ionizing radiation. Of note, Gadolinium-based contrast should be avoided as effects have not been well established in pregnancy (AJR Am J Roentgenol. 2008 Aug;191[2]:364-70).

If there is concern for malignancy during pregnancy, drawing serum tumor markers preoperatively is typically not suggested. Oncofetal antigens, including alpha fetoprotein (AFP), human chorionic gonadotropin (hCG), carcinoembryonic antigen (CEA), and cancer antigen 125 (CA-125), are elevated during gestation, making them poor markers for malignancy. If malignancy is ultimately diagnosed, then tumor markers can be obtained immediately postoperatively.

Surgical approach and prognosis

If there is low suspicion for malignancy, a laparoscopic approach is preferable and reasonable at all stages of pregnancy, although early second trimester is ideal. Entry at Palmer’s point in the left upper quadrant versus the umbilicus is preferable in order to minimize risk of uterine injury.

If malignancy is suspected, maximum exposure should be obtained with a midline vertical incision. Peritoneal washings should be obtained on immediate entry of the peritoneal cavity, and the contralateral ovary should also be adequately examined along with a general abdominopelvic survey. If the mass demonstrates concerning features, such as solid features or presence of ascites, then the specimen should be sent for intraoperative frozen pathology, and the pathologist should be made aware of the concurrent pregnancy. If malignancy is confirmed on frozen pathology, a full staging procedure should be performed and a gynecologic oncologist consulted.

Roughly three-quarters of invasive ovarian cancers diagnosed in pregnancy are early stage disease, and the 5-year survival of ovarian cancers associated with pregnancy is between 72% and 90% (Int J Gynecol Cancer. 2006 Jan-Feb;16[1]:8-15).

In a retrospective cohort study of 101 pregnant women, 31% of adnexal masses resected in pregnant women greater than 14 weeks gestation were teratomas. In total, 23% of masses were luteal cysts. Less commonly, patients were diagnosed with serous cystadenoma (14%), endometrioma (8%), mucinous cystadenoma (7%), benign cyst (6%), tumor of low malignant potential (5%), and paratubal cyst (3%).

In this study, approximately half of the women underwent minimally invasive surgery and half had surgery via laparotomy. There were more complications in the women undergoing laparotomy (ileus) and there were no differences between the groups with regards to pregnancy and neonatal outcomes (J Minim Invasive Gynecol. 2011 Nov-Dec;18[6]:720-5).

In general, characteristics that are favorable for spontaneous resolution include masses that are simple in nature by ultrasound and less than 5 cm to 6 cm in diameter.

For women with simple-appearing masses on ultrasound, reimaging can occur during the remainder of the pregnancy at the discretion of the physician or during the postpartum period. All women should be provided with torsion and rupture precautions during the pregnancy (Am J Obstet Gynecol. 2011 Aug;205[2]:97-102). For women with more concerning features on ultrasound, referral to a gynecologic oncologist is warranted. If the decision for surgical management is made, minimally invasive surgery should be strongly considered due to minimal maternal and perinatal morbidity.

Dr. Staley is a resident physician in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the university. They reported having no relevant financial disclosures.

Roughly 1%-2% of pregnancies are complicated by an adnexal mass, and prenatal ultrasound for fetal evaluation has detected more asymptomatic ovarian masses as a result.

The differential diagnosis for adnexal mass is broad and includes follicular or corpus luteum cysts, mature teratoma, theca lutein cyst, hydrosalpinx, endometrioma, cystadenoma, pedunculated leiomyoma, luteoma, as well as malignant neoplasms of epithelial, germ cell, and sex cord–stromal origin (J Ultrasound Med. 2004 Jun;23[6]:805-19). Most masses will be benign neoplasms, with a fraction identified as malignancies.

In 2013, Baser et al. performed a retrospective study of 151 women who underwent surgery of an adnexal mass at time of cesarean delivery. Of the 151 cases reviewed, 148 (98%) of the masses were benign (Int J Gynaecol Obstet. 2013 Nov;123[2]:124-6). Additionally, if the patient presents with pain, diagnoses such as ectopic pregnancy, heterotopic pregnancy, degenerating fibroid, and torsion should also be considered.

Diagnostic evaluation and management

The majority of adnexal masses identified in pregnancy are benign simple cysts measuring less than 5 cm in diameter. Approximately 70% of cystic masses detected in the first trimester will spontaneously resolve by the second trimester (Clin Obstet Gynecol. 2006 Sep;49[3]:492-505). However, for some masses, surgical resection is warranted.

Masses present after the first trimester and that are (1) greater than 10cm in diameter or (2) are solid or contain solid and cystic areas or have septated or papillary areas, are generally managed surgically as these features increase the risk of malignancy or complications such as adnexal torsion, rupture, or labor dystocia (Gynecol Oncol. 2006 May;101(2):315-21).

Adnexal masses without these features often resolve during pregnancy and can be expectantly managed (Obstet Gynecol. 2005 May;105[5 Pt 1]:1098-103). The optimal time for surgical intervention is after the first trimester as organogenesis is largely complete, therefore minimizing the risk of drug-induced teratogenesis, and any necessary cystectomy or oophorectomy will not disrupt the required progesterone production of the corpus luteum as this has been replaced by the placenta.

Preoperative assessment

For most cases, imaging with ultrasound is adequate for preoperative evaluation; however, in some cases, further imaging is needed for appropriate characterization of the mass. In this situation, further imaging with MRI is preferred as this modality has good resolution for visualization of soft tissue pathology and does not expose the patient and fetus to ionizing radiation. Of note, Gadolinium-based contrast should be avoided as effects have not been well established in pregnancy (AJR Am J Roentgenol. 2008 Aug;191[2]:364-70).

If there is concern for malignancy during pregnancy, drawing serum tumor markers preoperatively is typically not suggested. Oncofetal antigens, including alpha fetoprotein (AFP), human chorionic gonadotropin (hCG), carcinoembryonic antigen (CEA), and cancer antigen 125 (CA-125), are elevated during gestation, making them poor markers for malignancy. If malignancy is ultimately diagnosed, then tumor markers can be obtained immediately postoperatively.

Surgical approach and prognosis

If there is low suspicion for malignancy, a laparoscopic approach is preferable and reasonable at all stages of pregnancy, although early second trimester is ideal. Entry at Palmer’s point in the left upper quadrant versus the umbilicus is preferable in order to minimize risk of uterine injury.

If malignancy is suspected, maximum exposure should be obtained with a midline vertical incision. Peritoneal washings should be obtained on immediate entry of the peritoneal cavity, and the contralateral ovary should also be adequately examined along with a general abdominopelvic survey. If the mass demonstrates concerning features, such as solid features or presence of ascites, then the specimen should be sent for intraoperative frozen pathology, and the pathologist should be made aware of the concurrent pregnancy. If malignancy is confirmed on frozen pathology, a full staging procedure should be performed and a gynecologic oncologist consulted.

Roughly three-quarters of invasive ovarian cancers diagnosed in pregnancy are early stage disease, and the 5-year survival of ovarian cancers associated with pregnancy is between 72% and 90% (Int J Gynecol Cancer. 2006 Jan-Feb;16[1]:8-15).

In a retrospective cohort study of 101 pregnant women, 31% of adnexal masses resected in pregnant women greater than 14 weeks gestation were teratomas. In total, 23% of masses were luteal cysts. Less commonly, patients were diagnosed with serous cystadenoma (14%), endometrioma (8%), mucinous cystadenoma (7%), benign cyst (6%), tumor of low malignant potential (5%), and paratubal cyst (3%).

In this study, approximately half of the women underwent minimally invasive surgery and half had surgery via laparotomy. There were more complications in the women undergoing laparotomy (ileus) and there were no differences between the groups with regards to pregnancy and neonatal outcomes (J Minim Invasive Gynecol. 2011 Nov-Dec;18[6]:720-5).

In general, characteristics that are favorable for spontaneous resolution include masses that are simple in nature by ultrasound and less than 5 cm to 6 cm in diameter.

For women with simple-appearing masses on ultrasound, reimaging can occur during the remainder of the pregnancy at the discretion of the physician or during the postpartum period. All women should be provided with torsion and rupture precautions during the pregnancy (Am J Obstet Gynecol. 2011 Aug;205[2]:97-102). For women with more concerning features on ultrasound, referral to a gynecologic oncologist is warranted. If the decision for surgical management is made, minimally invasive surgery should be strongly considered due to minimal maternal and perinatal morbidity.

Dr. Staley is a resident physician in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the university. They reported having no relevant financial disclosures.

Roughly 1%-2% of pregnancies are complicated by an adnexal mass, and prenatal ultrasound for fetal evaluation has detected more asymptomatic ovarian masses as a result.

The differential diagnosis for adnexal mass is broad and includes follicular or corpus luteum cysts, mature teratoma, theca lutein cyst, hydrosalpinx, endometrioma, cystadenoma, pedunculated leiomyoma, luteoma, as well as malignant neoplasms of epithelial, germ cell, and sex cord–stromal origin (J Ultrasound Med. 2004 Jun;23[6]:805-19). Most masses will be benign neoplasms, with a fraction identified as malignancies.

In 2013, Baser et al. performed a retrospective study of 151 women who underwent surgery of an adnexal mass at time of cesarean delivery. Of the 151 cases reviewed, 148 (98%) of the masses were benign (Int J Gynaecol Obstet. 2013 Nov;123[2]:124-6). Additionally, if the patient presents with pain, diagnoses such as ectopic pregnancy, heterotopic pregnancy, degenerating fibroid, and torsion should also be considered.

Diagnostic evaluation and management

The majority of adnexal masses identified in pregnancy are benign simple cysts measuring less than 5 cm in diameter. Approximately 70% of cystic masses detected in the first trimester will spontaneously resolve by the second trimester (Clin Obstet Gynecol. 2006 Sep;49[3]:492-505). However, for some masses, surgical resection is warranted.

Masses present after the first trimester and that are (1) greater than 10cm in diameter or (2) are solid or contain solid and cystic areas or have septated or papillary areas, are generally managed surgically as these features increase the risk of malignancy or complications such as adnexal torsion, rupture, or labor dystocia (Gynecol Oncol. 2006 May;101(2):315-21).

Adnexal masses without these features often resolve during pregnancy and can be expectantly managed (Obstet Gynecol. 2005 May;105[5 Pt 1]:1098-103). The optimal time for surgical intervention is after the first trimester as organogenesis is largely complete, therefore minimizing the risk of drug-induced teratogenesis, and any necessary cystectomy or oophorectomy will not disrupt the required progesterone production of the corpus luteum as this has been replaced by the placenta.

Preoperative assessment

For most cases, imaging with ultrasound is adequate for preoperative evaluation; however, in some cases, further imaging is needed for appropriate characterization of the mass. In this situation, further imaging with MRI is preferred as this modality has good resolution for visualization of soft tissue pathology and does not expose the patient and fetus to ionizing radiation. Of note, Gadolinium-based contrast should be avoided as effects have not been well established in pregnancy (AJR Am J Roentgenol. 2008 Aug;191[2]:364-70).

If there is concern for malignancy during pregnancy, drawing serum tumor markers preoperatively is typically not suggested. Oncofetal antigens, including alpha fetoprotein (AFP), human chorionic gonadotropin (hCG), carcinoembryonic antigen (CEA), and cancer antigen 125 (CA-125), are elevated during gestation, making them poor markers for malignancy. If malignancy is ultimately diagnosed, then tumor markers can be obtained immediately postoperatively.

Surgical approach and prognosis

If there is low suspicion for malignancy, a laparoscopic approach is preferable and reasonable at all stages of pregnancy, although early second trimester is ideal. Entry at Palmer’s point in the left upper quadrant versus the umbilicus is preferable in order to minimize risk of uterine injury.

If malignancy is suspected, maximum exposure should be obtained with a midline vertical incision. Peritoneal washings should be obtained on immediate entry of the peritoneal cavity, and the contralateral ovary should also be adequately examined along with a general abdominopelvic survey. If the mass demonstrates concerning features, such as solid features or presence of ascites, then the specimen should be sent for intraoperative frozen pathology, and the pathologist should be made aware of the concurrent pregnancy. If malignancy is confirmed on frozen pathology, a full staging procedure should be performed and a gynecologic oncologist consulted.

Roughly three-quarters of invasive ovarian cancers diagnosed in pregnancy are early stage disease, and the 5-year survival of ovarian cancers associated with pregnancy is between 72% and 90% (Int J Gynecol Cancer. 2006 Jan-Feb;16[1]:8-15).

In a retrospective cohort study of 101 pregnant women, 31% of adnexal masses resected in pregnant women greater than 14 weeks gestation were teratomas. In total, 23% of masses were luteal cysts. Less commonly, patients were diagnosed with serous cystadenoma (14%), endometrioma (8%), mucinous cystadenoma (7%), benign cyst (6%), tumor of low malignant potential (5%), and paratubal cyst (3%).

In this study, approximately half of the women underwent minimally invasive surgery and half had surgery via laparotomy. There were more complications in the women undergoing laparotomy (ileus) and there were no differences between the groups with regards to pregnancy and neonatal outcomes (J Minim Invasive Gynecol. 2011 Nov-Dec;18[6]:720-5).

In general, characteristics that are favorable for spontaneous resolution include masses that are simple in nature by ultrasound and less than 5 cm to 6 cm in diameter.

For women with simple-appearing masses on ultrasound, reimaging can occur during the remainder of the pregnancy at the discretion of the physician or during the postpartum period. All women should be provided with torsion and rupture precautions during the pregnancy (Am J Obstet Gynecol. 2011 Aug;205[2]:97-102). For women with more concerning features on ultrasound, referral to a gynecologic oncologist is warranted. If the decision for surgical management is made, minimally invasive surgery should be strongly considered due to minimal maternal and perinatal morbidity.

Dr. Staley is a resident physician in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the university. They reported having no relevant financial disclosures.

SAN DIEGO – Blood levels of infliximab rose during pregnancy, while adalimumab levels remained stable, even after researchers accounted for changes in albumin, body mass index, and C-reactive protein levels, according to a novel single-center study of 25 women with inflammatory bowel disease (IBD).

Furthermore, blood levels of both anti–tumor necrosis factor agents varied considerably among patients, reported Dr. Cynthia Seow, a gastroenterologist at the University of Calgary (Alta.). “We should consider therapeutic drug monitoring during the prepregnancy period in order to optimize the dose during pregnancy,” she said. “Therapeutic drug monitoring may also be considered for pregnant women receiving infliximab in the second trimester to guide third-trimester dosing.

Active IBD during pregnancy increases the risk of relapse and preterm birth, Dr. Seow noted at the annual Digestive Diseases Week. Thus, infliximab and adalimumab are used to keep IBD in check during pregnancy, even though they cross the placenta and reach higher levels in the cord blood and newborn (Clin Gastroenterol Hepatol. 2013 March;11[3]:286-92) than in the mother. “However, it is not known how pregnancy itself influences the pharmacokinetics of anti-TNF agents, or the implications of this on prescribed dosing,” said Dr. Seow.

Therefore, she and her colleagues analyzed blood samples from 25 women receiving stable maintenance anti-TNF therapy for IBD, who attended a median of three prenatal visits at the University of Calgary IBD Pregnancy Clinic. Fifteen women received infliximab during 15 pregnancies, and 10 women received adalimumab during 11 pregnancies. Infliximab levels were drawn at trough times, while adalimumab levels were usually drawn 3 days before the next injection. Blood samples were tested only after delivery, and anti-TNF doses were not adjusted during pregnancy.

The infliximab group included eight women with Crohn’s disease and seven women with ulcerative colitis, and the adalimumab group included nine women with Crohn’s disease and one with ulcerative colitis, said Dr. Seow. The treatment groups were similar in terms of age at diagnosis and pregnancy, time on anti-TNF agents, and average gestational age at delivery, which was 39.2 weeks (range, 38.1-40.2 weeks) for the infliximab group and 38.4 weeks (range, 37.2-39.6 weeks) for the adalimumab patients.

Median infliximab concentrations rose from 8.5 mcg/mL in the first trimester to a peak of 21 mcg/mL during the middle of the third trimester (P = .04), and then dropped to nearly preconception levels after delivery, Dr. Seow reported. “This change persisted irrespective of disease phenotype,” she added. Albumin levels correlated inversely with infliximab levels. In contrast, median adalimumab levels ranged between 8.6 and 12.2 mcg/mL during pregnancy, dropped to 6.8 mcg/mL after birth, and were unrelated to albumin levels.

Body mass index and C-reactive protein levels did not affect blood levels of either drug, and the researchers found no differences in pharmacokinetics in subgroups of patients who had only two blood draws, subtherapeutic drug levels, or consistently absent drug levels, Dr. Seow said. Three patients had detectable antibodies during pregnancy, all of whom had a stable clinical course, she said. “The antibody levels appeared to decrease as the pregnancy progressed, and then appeared to increase again after delivery.” A third of infliximab patients and nearly half of adalimumab patients were receiving combination treatments for IBD, and their anti-TNF blood levels resembled those of patients on monotherapy, she also noted.

The researchers did not test cord blood or blood sample from the newborns, but based on past evidence, fetal anti-TNF exposure has implications for current live vaccination recommendations in infants, Dr. Seow emphasized. “The long-term consequences of anti-TNF exposure remain unknown,” she concluded.

Dr. Seow disclosed ties with Janssen, AbbVie, Takeda, Shire, and Actavis.

SAN DIEGO – Blood levels of infliximab rose during pregnancy, while adalimumab levels remained stable, even after researchers accounted for changes in albumin, body mass index, and C-reactive protein levels, according to a novel single-center study of 25 women with inflammatory bowel disease (IBD).

Furthermore, blood levels of both anti–tumor necrosis factor agents varied considerably among patients, reported Dr. Cynthia Seow, a gastroenterologist at the University of Calgary (Alta.). “We should consider therapeutic drug monitoring during the prepregnancy period in order to optimize the dose during pregnancy,” she said. “Therapeutic drug monitoring may also be considered for pregnant women receiving infliximab in the second trimester to guide third-trimester dosing.

Active IBD during pregnancy increases the risk of relapse and preterm birth, Dr. Seow noted at the annual Digestive Diseases Week. Thus, infliximab and adalimumab are used to keep IBD in check during pregnancy, even though they cross the placenta and reach higher levels in the cord blood and newborn (Clin Gastroenterol Hepatol. 2013 March;11[3]:286-92) than in the mother. “However, it is not known how pregnancy itself influences the pharmacokinetics of anti-TNF agents, or the implications of this on prescribed dosing,” said Dr. Seow.

Therefore, she and her colleagues analyzed blood samples from 25 women receiving stable maintenance anti-TNF therapy for IBD, who attended a median of three prenatal visits at the University of Calgary IBD Pregnancy Clinic. Fifteen women received infliximab during 15 pregnancies, and 10 women received adalimumab during 11 pregnancies. Infliximab levels were drawn at trough times, while adalimumab levels were usually drawn 3 days before the next injection. Blood samples were tested only after delivery, and anti-TNF doses were not adjusted during pregnancy.

The infliximab group included eight women with Crohn’s disease and seven women with ulcerative colitis, and the adalimumab group included nine women with Crohn’s disease and one with ulcerative colitis, said Dr. Seow. The treatment groups were similar in terms of age at diagnosis and pregnancy, time on anti-TNF agents, and average gestational age at delivery, which was 39.2 weeks (range, 38.1-40.2 weeks) for the infliximab group and 38.4 weeks (range, 37.2-39.6 weeks) for the adalimumab patients.

Median infliximab concentrations rose from 8.5 mcg/mL in the first trimester to a peak of 21 mcg/mL during the middle of the third trimester (P = .04), and then dropped to nearly preconception levels after delivery, Dr. Seow reported. “This change persisted irrespective of disease phenotype,” she added. Albumin levels correlated inversely with infliximab levels. In contrast, median adalimumab levels ranged between 8.6 and 12.2 mcg/mL during pregnancy, dropped to 6.8 mcg/mL after birth, and were unrelated to albumin levels.

Body mass index and C-reactive protein levels did not affect blood levels of either drug, and the researchers found no differences in pharmacokinetics in subgroups of patients who had only two blood draws, subtherapeutic drug levels, or consistently absent drug levels, Dr. Seow said. Three patients had detectable antibodies during pregnancy, all of whom had a stable clinical course, she said. “The antibody levels appeared to decrease as the pregnancy progressed, and then appeared to increase again after delivery.” A third of infliximab patients and nearly half of adalimumab patients were receiving combination treatments for IBD, and their anti-TNF blood levels resembled those of patients on monotherapy, she also noted.

The researchers did not test cord blood or blood sample from the newborns, but based on past evidence, fetal anti-TNF exposure has implications for current live vaccination recommendations in infants, Dr. Seow emphasized. “The long-term consequences of anti-TNF exposure remain unknown,” she concluded.

Dr. Seow disclosed ties with Janssen, AbbVie, Takeda, Shire, and Actavis.

SAN DIEGO – Blood levels of infliximab rose during pregnancy, while adalimumab levels remained stable, even after researchers accounted for changes in albumin, body mass index, and C-reactive protein levels, according to a novel single-center study of 25 women with inflammatory bowel disease (IBD).

Furthermore, blood levels of both anti–tumor necrosis factor agents varied considerably among patients, reported Dr. Cynthia Seow, a gastroenterologist at the University of Calgary (Alta.). “We should consider therapeutic drug monitoring during the prepregnancy period in order to optimize the dose during pregnancy,” she said. “Therapeutic drug monitoring may also be considered for pregnant women receiving infliximab in the second trimester to guide third-trimester dosing.

Active IBD during pregnancy increases the risk of relapse and preterm birth, Dr. Seow noted at the annual Digestive Diseases Week. Thus, infliximab and adalimumab are used to keep IBD in check during pregnancy, even though they cross the placenta and reach higher levels in the cord blood and newborn (Clin Gastroenterol Hepatol. 2013 March;11[3]:286-92) than in the mother. “However, it is not known how pregnancy itself influences the pharmacokinetics of anti-TNF agents, or the implications of this on prescribed dosing,” said Dr. Seow.

Therefore, she and her colleagues analyzed blood samples from 25 women receiving stable maintenance anti-TNF therapy for IBD, who attended a median of three prenatal visits at the University of Calgary IBD Pregnancy Clinic. Fifteen women received infliximab during 15 pregnancies, and 10 women received adalimumab during 11 pregnancies. Infliximab levels were drawn at trough times, while adalimumab levels were usually drawn 3 days before the next injection. Blood samples were tested only after delivery, and anti-TNF doses were not adjusted during pregnancy.

The infliximab group included eight women with Crohn’s disease and seven women with ulcerative colitis, and the adalimumab group included nine women with Crohn’s disease and one with ulcerative colitis, said Dr. Seow. The treatment groups were similar in terms of age at diagnosis and pregnancy, time on anti-TNF agents, and average gestational age at delivery, which was 39.2 weeks (range, 38.1-40.2 weeks) for the infliximab group and 38.4 weeks (range, 37.2-39.6 weeks) for the adalimumab patients.

Median infliximab concentrations rose from 8.5 mcg/mL in the first trimester to a peak of 21 mcg/mL during the middle of the third trimester (P = .04), and then dropped to nearly preconception levels after delivery, Dr. Seow reported. “This change persisted irrespective of disease phenotype,” she added. Albumin levels correlated inversely with infliximab levels. In contrast, median adalimumab levels ranged between 8.6 and 12.2 mcg/mL during pregnancy, dropped to 6.8 mcg/mL after birth, and were unrelated to albumin levels.

Body mass index and C-reactive protein levels did not affect blood levels of either drug, and the researchers found no differences in pharmacokinetics in subgroups of patients who had only two blood draws, subtherapeutic drug levels, or consistently absent drug levels, Dr. Seow said. Three patients had detectable antibodies during pregnancy, all of whom had a stable clinical course, she said. “The antibody levels appeared to decrease as the pregnancy progressed, and then appeared to increase again after delivery.” A third of infliximab patients and nearly half of adalimumab patients were receiving combination treatments for IBD, and their anti-TNF blood levels resembled those of patients on monotherapy, she also noted.

The researchers did not test cord blood or blood sample from the newborns, but based on past evidence, fetal anti-TNF exposure has implications for current live vaccination recommendations in infants, Dr. Seow emphasized. “The long-term consequences of anti-TNF exposure remain unknown,” she concluded.

Dr. Seow disclosed ties with Janssen, AbbVie, Takeda, Shire, and Actavis.

WASHINGTON – The rate of cesarean delivery surgical site infections fell significantly at Yale New Haven (Conn.) Hospital after implementation of a multidisciplinary care bundle with protocols covering preoperative, intraoperative, and postoperative care.

An analysis of two 3-month sampling periods – one before implementation of the bundle of care and one after – showed a drop in the surgical site infection (SSI) rate among total cesarean sections from 3.4% to 2.2%.

At the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Ashley Pritchard of the hospital described the care bundle and urged obstetricians to consider the impact of even small reductions in SSIs after a cesarean.

Martin Valigursky/Thinkstock

“Infection is the most common complication following cesarean delivery … 2.5%-16% of all cesarean deliveries will result in a surgical site infection, and there is significant underestimation as between 15% to 80% of infections are diagnosed after patients leave the hospital,” she said.

A cesarean delivery SSI task force created by the hospital’s obstetric patient safety program developed the care bundle after reviewing best practices, guidelines, and evidence-based reviews.

Preoperative protocols for planned cesareans focused on patient education and included a preoperative appointment and instructions for showering the night before surgery, not shaving for more than 24 hours prior to scheduled surgery, using 2% chlorhexidine wipes both the night prior to surgery and the day of surgery, and other hygiene processes.

“We know from numerous studies that chlorhexidine is superior to iodine, but we also have found that with these wipes you get a level of antibiosis on the skin surface that decreases surgical site infections at the time of incisions,” Dr. Pritchard said.

For the operative care part of the bundle, staff were reeducated about the scrubbing protocol, proper attire and limits on operating room traffic, and the correct and timely use of antibiotics (for example, a cephalosporin administered within 30 minutes of incision). Staff also watched a video and were quizzed on the proper technique and timing for preoperative skin preparation.

Increased attention was paid to normothermia and included preoperative use of warming blankets and proper temperature in the operating room and post–anesthesia care unit.

“We’ve learned from colorectal and trauma surgery that normothermia and patient warming lead to reduced SSI,” Dr. Pritchard said. “This hasn’t been proven with cesarean delivery, but we know there’s improved maternal and fetal well-being with preoperative warming.”

Postoperatively, the use of supplemental oxygen was discontinued unless clinically indicated “since it’s been shown to have no positive effect on SSI,” she said. Incision dressing application and removal were also standardized, with sterile dressings maintained for at least 24 hours – with a tag labeling the date and time of application – and no more than 48 hours. At discharge, patients were given clear discharge instructions and a postpartum appointment for an incision check.

During the 3-month sampling period prior to implementation of the care bundle, there were 382 cesarean deliveries, and 147 patients presented for a postpartum appointment (either the prescribed visit or a later “issue visit”) within 30 days (38%). Of these patients, 8.6% were diagnosed with an SSI.

In the postimplementation sampling period, which began 6 months after rollout, there were 361 cesarean deliveries at the hospital, and 297 patients (77%) presented for postpartum care. Of these patients, 2.9% were diagnosed with an SSI.

An analysis based on the total number of cesarean deliveries performed at the hospital (planned and unplanned) during the two 3-month periods showed a decline in the cesarean delivery SSI rate from 3.4% to 2.2%. “This is statistically significant. It shows a dramatic decline in the SSI rate in our patient population … a clear impact of the bundle of care,” Dr. Pritchard said.

The Yale team attributes the significant increase in postoperative visit attendance to the preoperative protocol for planned cesareans. “We think it had something to do with our creating better relationships by having [patients] present preoperatively and starting their care prior to incision,” she said.

The preoperative visit also provided an opportunity to identify and treat any active skin infections, upper respiratory infections, or chronic colonizations (without evidence of completion of treatment) before delivery. “If necessary and if possible, [we could] push back their cesarean section date to ensure adequate treatment had been achieved,” Dr. Pritchard said.

All aspects of the care bundle were rolled out simultaneously. Next steps for the New Haven team include further analysis of provider and patient views, a look at the sustainability of the bundle of care and its impact, and a cost analysis. “We reduced our SSIs, but we’ve also added a number of elements to our care spectrum, pre- and postoperatively,” Dr. Pritchard said.

For now, one thing seems clear: “We learned from cardiac and colorectal surgery that there really is strength in the bundle, that the sum of the parts is greater than the individual aspects,” she said.

Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.

WASHINGTON – The rate of cesarean delivery surgical site infections fell significantly at Yale New Haven (Conn.) Hospital after implementation of a multidisciplinary care bundle with protocols covering preoperative, intraoperative, and postoperative care.

An analysis of two 3-month sampling periods – one before implementation of the bundle of care and one after – showed a drop in the surgical site infection (SSI) rate among total cesarean sections from 3.4% to 2.2%.

At the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Ashley Pritchard of the hospital described the care bundle and urged obstetricians to consider the impact of even small reductions in SSIs after a cesarean.

Martin Valigursky/Thinkstock

“Infection is the most common complication following cesarean delivery … 2.5%-16% of all cesarean deliveries will result in a surgical site infection, and there is significant underestimation as between 15% to 80% of infections are diagnosed after patients leave the hospital,” she said.

A cesarean delivery SSI task force created by the hospital’s obstetric patient safety program developed the care bundle after reviewing best practices, guidelines, and evidence-based reviews.

Preoperative protocols for planned cesareans focused on patient education and included a preoperative appointment and instructions for showering the night before surgery, not shaving for more than 24 hours prior to scheduled surgery, using 2% chlorhexidine wipes both the night prior to surgery and the day of surgery, and other hygiene processes.

“We know from numerous studies that chlorhexidine is superior to iodine, but we also have found that with these wipes you get a level of antibiosis on the skin surface that decreases surgical site infections at the time of incisions,” Dr. Pritchard said.

For the operative care part of the bundle, staff were reeducated about the scrubbing protocol, proper attire and limits on operating room traffic, and the correct and timely use of antibiotics (for example, a cephalosporin administered within 30 minutes of incision). Staff also watched a video and were quizzed on the proper technique and timing for preoperative skin preparation.

Increased attention was paid to normothermia and included preoperative use of warming blankets and proper temperature in the operating room and post–anesthesia care unit.

“We’ve learned from colorectal and trauma surgery that normothermia and patient warming lead to reduced SSI,” Dr. Pritchard said. “This hasn’t been proven with cesarean delivery, but we know there’s improved maternal and fetal well-being with preoperative warming.”

Postoperatively, the use of supplemental oxygen was discontinued unless clinically indicated “since it’s been shown to have no positive effect on SSI,” she said. Incision dressing application and removal were also standardized, with sterile dressings maintained for at least 24 hours – with a tag labeling the date and time of application – and no more than 48 hours. At discharge, patients were given clear discharge instructions and a postpartum appointment for an incision check.

During the 3-month sampling period prior to implementation of the care bundle, there were 382 cesarean deliveries, and 147 patients presented for a postpartum appointment (either the prescribed visit or a later “issue visit”) within 30 days (38%). Of these patients, 8.6% were diagnosed with an SSI.

In the postimplementation sampling period, which began 6 months after rollout, there were 361 cesarean deliveries at the hospital, and 297 patients (77%) presented for postpartum care. Of these patients, 2.9% were diagnosed with an SSI.

An analysis based on the total number of cesarean deliveries performed at the hospital (planned and unplanned) during the two 3-month periods showed a decline in the cesarean delivery SSI rate from 3.4% to 2.2%. “This is statistically significant. It shows a dramatic decline in the SSI rate in our patient population … a clear impact of the bundle of care,” Dr. Pritchard said.

The Yale team attributes the significant increase in postoperative visit attendance to the preoperative protocol for planned cesareans. “We think it had something to do with our creating better relationships by having [patients] present preoperatively and starting their care prior to incision,” she said.

The preoperative visit also provided an opportunity to identify and treat any active skin infections, upper respiratory infections, or chronic colonizations (without evidence of completion of treatment) before delivery. “If necessary and if possible, [we could] push back their cesarean section date to ensure adequate treatment had been achieved,” Dr. Pritchard said.

All aspects of the care bundle were rolled out simultaneously. Next steps for the New Haven team include further analysis of provider and patient views, a look at the sustainability of the bundle of care and its impact, and a cost analysis. “We reduced our SSIs, but we’ve also added a number of elements to our care spectrum, pre- and postoperatively,” Dr. Pritchard said.

For now, one thing seems clear: “We learned from cardiac and colorectal surgery that there really is strength in the bundle, that the sum of the parts is greater than the individual aspects,” she said.

Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.

WASHINGTON – The rate of cesarean delivery surgical site infections fell significantly at Yale New Haven (Conn.) Hospital after implementation of a multidisciplinary care bundle with protocols covering preoperative, intraoperative, and postoperative care.

An analysis of two 3-month sampling periods – one before implementation of the bundle of care and one after – showed a drop in the surgical site infection (SSI) rate among total cesarean sections from 3.4% to 2.2%.

At the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Ashley Pritchard of the hospital described the care bundle and urged obstetricians to consider the impact of even small reductions in SSIs after a cesarean.

Martin Valigursky/Thinkstock

“Infection is the most common complication following cesarean delivery … 2.5%-16% of all cesarean deliveries will result in a surgical site infection, and there is significant underestimation as between 15% to 80% of infections are diagnosed after patients leave the hospital,” she said.

A cesarean delivery SSI task force created by the hospital’s obstetric patient safety program developed the care bundle after reviewing best practices, guidelines, and evidence-based reviews.

Preoperative protocols for planned cesareans focused on patient education and included a preoperative appointment and instructions for showering the night before surgery, not shaving for more than 24 hours prior to scheduled surgery, using 2% chlorhexidine wipes both the night prior to surgery and the day of surgery, and other hygiene processes.

“We know from numerous studies that chlorhexidine is superior to iodine, but we also have found that with these wipes you get a level of antibiosis on the skin surface that decreases surgical site infections at the time of incisions,” Dr. Pritchard said.

For the operative care part of the bundle, staff were reeducated about the scrubbing protocol, proper attire and limits on operating room traffic, and the correct and timely use of antibiotics (for example, a cephalosporin administered within 30 minutes of incision). Staff also watched a video and were quizzed on the proper technique and timing for preoperative skin preparation.

Increased attention was paid to normothermia and included preoperative use of warming blankets and proper temperature in the operating room and post–anesthesia care unit.

“We’ve learned from colorectal and trauma surgery that normothermia and patient warming lead to reduced SSI,” Dr. Pritchard said. “This hasn’t been proven with cesarean delivery, but we know there’s improved maternal and fetal well-being with preoperative warming.”

Postoperatively, the use of supplemental oxygen was discontinued unless clinically indicated “since it’s been shown to have no positive effect on SSI,” she said. Incision dressing application and removal were also standardized, with sterile dressings maintained for at least 24 hours – with a tag labeling the date and time of application – and no more than 48 hours. At discharge, patients were given clear discharge instructions and a postpartum appointment for an incision check.

During the 3-month sampling period prior to implementation of the care bundle, there were 382 cesarean deliveries, and 147 patients presented for a postpartum appointment (either the prescribed visit or a later “issue visit”) within 30 days (38%). Of these patients, 8.6% were diagnosed with an SSI.

In the postimplementation sampling period, which began 6 months after rollout, there were 361 cesarean deliveries at the hospital, and 297 patients (77%) presented for postpartum care. Of these patients, 2.9% were diagnosed with an SSI.

An analysis based on the total number of cesarean deliveries performed at the hospital (planned and unplanned) during the two 3-month periods showed a decline in the cesarean delivery SSI rate from 3.4% to 2.2%. “This is statistically significant. It shows a dramatic decline in the SSI rate in our patient population … a clear impact of the bundle of care,” Dr. Pritchard said.

The Yale team attributes the significant increase in postoperative visit attendance to the preoperative protocol for planned cesareans. “We think it had something to do with our creating better relationships by having [patients] present preoperatively and starting their care prior to incision,” she said.

The preoperative visit also provided an opportunity to identify and treat any active skin infections, upper respiratory infections, or chronic colonizations (without evidence of completion of treatment) before delivery. “If necessary and if possible, [we could] push back their cesarean section date to ensure adequate treatment had been achieved,” Dr. Pritchard said.

All aspects of the care bundle were rolled out simultaneously. Next steps for the New Haven team include further analysis of provider and patient views, a look at the sustainability of the bundle of care and its impact, and a cost analysis. “We reduced our SSIs, but we’ve also added a number of elements to our care spectrum, pre- and postoperatively,” Dr. Pritchard said.

For now, one thing seems clear: “We learned from cardiac and colorectal surgery that there really is strength in the bundle, that the sum of the parts is greater than the individual aspects,” she said.

Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.

Tasked with tackling the literature on the subject and debating the question of whether or not it is best to electively induce labor in women with low-risk pregnancies at 39 weeks (vs at 41 weeks after expectant management), Errol Norwitz, MD, PhD, Chairman of the Department of Obstetrics and Gynecology and Professor at Tufts University School of Medicine in Boston, Massachusetts, and Charles Lockwood, MD, Senior Vice President at the University of South Florida (USF) and Dean of the USF Health Morsani College of Medicine in Tampa came to the same conclusion: Elective induction of labor (eIOL) at 39 weeks is superior to expectant management when it comes to fetal outcomes.

In addition, they both agreed that complication rates to the mother (ie, number of cesarean deliveries [CDs]) would not be increased, and possibly even reduced, with eIOL at 39 weeks versus 41 weeks. Dr. Norwitz postulated that, with IOL there is no increase in CD rate in multiparous women and nulliparous women with a favorable cervical exam but that there likely could be an increase in the CD rate for nulliparous women with an unfavorable cervical exam.

The finding that eIOL at 39 weeks is better than at 41 weeks for the infant is likely due to a bigger baby size past 39 weeks (with more traumatic deliveries) and higher rates of postmaturity complications, said Dr. Lockwood. And for the mother, eIOL at 39 weeks can reduce risks—of preeclampsia, abruption, sepsis, and others—the presenters pointed out.

Arriving at their conclusions: The dataDr. Norwitz explained the challenge before them in this unusual “debate.” “In ObGyn we all read the same literature but we often come away with very different takes as to what the implications are and how we incorporate this into our management algorithms. Instead of taking a pro/con approach, with one assigned to ‘yes’ and the other assigned to ‘no,’ and selectively picking out the literature to support our positions, what we did was we each went away, read the literature, synthesized it, and tried to answer this question for ourselves.”

Dr. Norwitz, who is widely published and known for his research on the causes and prevention of preeclampsia and preterm labor, examined and presented the published literature for benefit and harms to the fetus and mother in continuing pregnancy past 39 weeks.

Dr. Lockwood also examined the literature, including a large population cohort of about 1.27 million women that examined CD rates, perinatal mortality, and neonatal and maternal outcomes of eIOL at 39 weeks versus expectant management.¹ He presented, however, that the best evidence to compare the question at hand would be a randomized clinical trial comparing specifically eIOL at 39 weeks versus expectant management, with IOL at 41 weeks. To be powered to detect a difference in perinatal and maternal mortality, this trial would need to include 2.2 to 12.6 million women, he maintained. “When empirical evidence doesn’t exist, the only alternative is some kind of other modeling,” he said. Therefore, he and a team of researchers conducted a Monte Carlo microsimulation modeling decision analysis, taking into account “all outcomes and all preferences that we possibly could cull from the literature.”

Which women actually could benefit from eIOL at 39 weeks?Women with high-risk pregnancies were not included in this debate or considered. Dr. Norwitz clearly defined his case patient at the outset as a 22-year-old G1 at 39 0/7 weeks who has had an uncomplicated pregnancy but is now complaining of decreased fetal movement and tells you that she is worried because her sister lost her baby at 40 weeks to stillbirth. She specifically asks, “Doctor, why can’t you induce my labor now?” 

What counseling a patient about the risks/benefits of eIOL at 39 weeks would requireTwo fundamentals would need to be ensured. The first: precise gestational dating. Dr. Norwitz pointed out that menstrual history can be inaccurate, especially in women with irregular cycles, who are taking hormonal contraception, or who have intermenstrual bleeding. “Early dating ultrasound is the best way to date pregnancies and probably should be done routinely,” although it is not currently standard of care in the United States, he said.

The second fundamental: a true induction of labor process, not one that involves “stopping at 5 PM,” said Dr. Lockwood.

“Although Dr. Lockwood’s 5-PM statement was made tongue-in-cheek,” said Dr. Norwitz after the debate, “he certainly was implying that a genuine effort should be made to effect a vaginal delivery—that is, giving the most effective cervical ripening agents, allowing enough time to pass, and defining clearly the criteria for failed IOL. You shouldn’t just throw the towel in at 5 PM because you want to go home.”

Cost implicationsElectively inducing labor in all women with low-risk pregnancies at 39 weeks is a strategy with unknown cost implications, and the cost difference between this strategy and expectant management up to 41 weeks is not known.

“We need to be sure that we understand the cost implications of these strategies, which of course would need to be balanced against the potential perinatal and maternal morbidity and fetal death,” said Dr. Lockwood.

The meaning of “elective”Dr. Norwitz also made the point postdebate that the American College of Obstetricians and Gynecologists (ACOG) does not support elective IOL prior to 39 weeks’ gestation. “The key term here is ‘elective,’" he said, "which refers to a delivery without a clear medical or obstetric indication. ACOG does support delivery prior to 39 weeks’ gestation, there just needs to be an appropriate indication.”

Tasked with tackling the literature on the subject and debating the question of whether or not it is best to electively induce labor in women with low-risk pregnancies at 39 weeks (vs at 41 weeks after expectant management), Errol Norwitz, MD, PhD, Chairman of the Department of Obstetrics and Gynecology and Professor at Tufts University School of Medicine in Boston, Massachusetts, and Charles Lockwood, MD, Senior Vice President at the University of South Florida (USF) and Dean of the USF Health Morsani College of Medicine in Tampa came to the same conclusion: Elective induction of labor (eIOL) at 39 weeks is superior to expectant management when it comes to fetal outcomes.

In addition, they both agreed that complication rates to the mother (ie, number of cesarean deliveries [CDs]) would not be increased, and possibly even reduced, with eIOL at 39 weeks versus 41 weeks. Dr. Norwitz postulated that, with IOL there is no increase in CD rate in multiparous women and nulliparous women with a favorable cervical exam but that there likely could be an increase in the CD rate for nulliparous women with an unfavorable cervical exam.

The finding that eIOL at 39 weeks is better than at 41 weeks for the infant is likely due to a bigger baby size past 39 weeks (with more traumatic deliveries) and higher rates of postmaturity complications, said Dr. Lockwood. And for the mother, eIOL at 39 weeks can reduce risks—of preeclampsia, abruption, sepsis, and others—the presenters pointed out.

Arriving at their conclusions: The dataDr. Norwitz explained the challenge before them in this unusual “debate.” “In ObGyn we all read the same literature but we often come away with very different takes as to what the implications are and how we incorporate this into our management algorithms. Instead of taking a pro/con approach, with one assigned to ‘yes’ and the other assigned to ‘no,’ and selectively picking out the literature to support our positions, what we did was we each went away, read the literature, synthesized it, and tried to answer this question for ourselves.”

Dr. Norwitz, who is widely published and known for his research on the causes and prevention of preeclampsia and preterm labor, examined and presented the published literature for benefit and harms to the fetus and mother in continuing pregnancy past 39 weeks.

Dr. Lockwood also examined the literature, including a large population cohort of about 1.27 million women that examined CD rates, perinatal mortality, and neonatal and maternal outcomes of eIOL at 39 weeks versus expectant management.¹ He presented, however, that the best evidence to compare the question at hand would be a randomized clinical trial comparing specifically eIOL at 39 weeks versus expectant management, with IOL at 41 weeks. To be powered to detect a difference in perinatal and maternal mortality, this trial would need to include 2.2 to 12.6 million women, he maintained. “When empirical evidence doesn’t exist, the only alternative is some kind of other modeling,” he said. Therefore, he and a team of researchers conducted a Monte Carlo microsimulation modeling decision analysis, taking into account “all outcomes and all preferences that we possibly could cull from the literature.”

Which women actually could benefit from eIOL at 39 weeks?Women with high-risk pregnancies were not included in this debate or considered. Dr. Norwitz clearly defined his case patient at the outset as a 22-year-old G1 at 39 0/7 weeks who has had an uncomplicated pregnancy but is now complaining of decreased fetal movement and tells you that she is worried because her sister lost her baby at 40 weeks to stillbirth. She specifically asks, “Doctor, why can’t you induce my labor now?” 

What counseling a patient about the risks/benefits of eIOL at 39 weeks would requireTwo fundamentals would need to be ensured. The first: precise gestational dating. Dr. Norwitz pointed out that menstrual history can be inaccurate, especially in women with irregular cycles, who are taking hormonal contraception, or who have intermenstrual bleeding. “Early dating ultrasound is the best way to date pregnancies and probably should be done routinely,” although it is not currently standard of care in the United States, he said.

The second fundamental: a true induction of labor process, not one that involves “stopping at 5 PM,” said Dr. Lockwood.

“Although Dr. Lockwood’s 5-PM statement was made tongue-in-cheek,” said Dr. Norwitz after the debate, “he certainly was implying that a genuine effort should be made to effect a vaginal delivery—that is, giving the most effective cervical ripening agents, allowing enough time to pass, and defining clearly the criteria for failed IOL. You shouldn’t just throw the towel in at 5 PM because you want to go home.”

Cost implicationsElectively inducing labor in all women with low-risk pregnancies at 39 weeks is a strategy with unknown cost implications, and the cost difference between this strategy and expectant management up to 41 weeks is not known.

“We need to be sure that we understand the cost implications of these strategies, which of course would need to be balanced against the potential perinatal and maternal morbidity and fetal death,” said Dr. Lockwood.

The meaning of “elective”Dr. Norwitz also made the point postdebate that the American College of Obstetricians and Gynecologists (ACOG) does not support elective IOL prior to 39 weeks’ gestation. “The key term here is ‘elective,’" he said, "which refers to a delivery without a clear medical or obstetric indication. ACOG does support delivery prior to 39 weeks’ gestation, there just needs to be an appropriate indication.”

Tasked with tackling the literature on the subject and debating the question of whether or not it is best to electively induce labor in women with low-risk pregnancies at 39 weeks (vs at 41 weeks after expectant management), Errol Norwitz, MD, PhD, Chairman of the Department of Obstetrics and Gynecology and Professor at Tufts University School of Medicine in Boston, Massachusetts, and Charles Lockwood, MD, Senior Vice President at the University of South Florida (USF) and Dean of the USF Health Morsani College of Medicine in Tampa came to the same conclusion: Elective induction of labor (eIOL) at 39 weeks is superior to expectant management when it comes to fetal outcomes.

In addition, they both agreed that complication rates to the mother (ie, number of cesarean deliveries [CDs]) would not be increased, and possibly even reduced, with eIOL at 39 weeks versus 41 weeks. Dr. Norwitz postulated that, with IOL there is no increase in CD rate in multiparous women and nulliparous women with a favorable cervical exam but that there likely could be an increase in the CD rate for nulliparous women with an unfavorable cervical exam.

The finding that eIOL at 39 weeks is better than at 41 weeks for the infant is likely due to a bigger baby size past 39 weeks (with more traumatic deliveries) and higher rates of postmaturity complications, said Dr. Lockwood. And for the mother, eIOL at 39 weeks can reduce risks—of preeclampsia, abruption, sepsis, and others—the presenters pointed out.

Arriving at their conclusions: The dataDr. Norwitz explained the challenge before them in this unusual “debate.” “In ObGyn we all read the same literature but we often come away with very different takes as to what the implications are and how we incorporate this into our management algorithms. Instead of taking a pro/con approach, with one assigned to ‘yes’ and the other assigned to ‘no,’ and selectively picking out the literature to support our positions, what we did was we each went away, read the literature, synthesized it, and tried to answer this question for ourselves.”

Dr. Norwitz, who is widely published and known for his research on the causes and prevention of preeclampsia and preterm labor, examined and presented the published literature for benefit and harms to the fetus and mother in continuing pregnancy past 39 weeks.

Dr. Lockwood also examined the literature, including a large population cohort of about 1.27 million women that examined CD rates, perinatal mortality, and neonatal and maternal outcomes of eIOL at 39 weeks versus expectant management.¹ He presented, however, that the best evidence to compare the question at hand would be a randomized clinical trial comparing specifically eIOL at 39 weeks versus expectant management, with IOL at 41 weeks. To be powered to detect a difference in perinatal and maternal mortality, this trial would need to include 2.2 to 12.6 million women, he maintained. “When empirical evidence doesn’t exist, the only alternative is some kind of other modeling,” he said. Therefore, he and a team of researchers conducted a Monte Carlo microsimulation modeling decision analysis, taking into account “all outcomes and all preferences that we possibly could cull from the literature.”

Which women actually could benefit from eIOL at 39 weeks?Women with high-risk pregnancies were not included in this debate or considered. Dr. Norwitz clearly defined his case patient at the outset as a 22-year-old G1 at 39 0/7 weeks who has had an uncomplicated pregnancy but is now complaining of decreased fetal movement and tells you that she is worried because her sister lost her baby at 40 weeks to stillbirth. She specifically asks, “Doctor, why can’t you induce my labor now?” 

What counseling a patient about the risks/benefits of eIOL at 39 weeks would requireTwo fundamentals would need to be ensured. The first: precise gestational dating. Dr. Norwitz pointed out that menstrual history can be inaccurate, especially in women with irregular cycles, who are taking hormonal contraception, or who have intermenstrual bleeding. “Early dating ultrasound is the best way to date pregnancies and probably should be done routinely,” although it is not currently standard of care in the United States, he said.

The second fundamental: a true induction of labor process, not one that involves “stopping at 5 PM,” said Dr. Lockwood.

“Although Dr. Lockwood’s 5-PM statement was made tongue-in-cheek,” said Dr. Norwitz after the debate, “he certainly was implying that a genuine effort should be made to effect a vaginal delivery—that is, giving the most effective cervical ripening agents, allowing enough time to pass, and defining clearly the criteria for failed IOL. You shouldn’t just throw the towel in at 5 PM because you want to go home.”

Cost implicationsElectively inducing labor in all women with low-risk pregnancies at 39 weeks is a strategy with unknown cost implications, and the cost difference between this strategy and expectant management up to 41 weeks is not known.

“We need to be sure that we understand the cost implications of these strategies, which of course would need to be balanced against the potential perinatal and maternal morbidity and fetal death,” said Dr. Lockwood.

The meaning of “elective”Dr. Norwitz also made the point postdebate that the American College of Obstetricians and Gynecologists (ACOG) does not support elective IOL prior to 39 weeks’ gestation. “The key term here is ‘elective,’" he said, "which refers to a delivery without a clear medical or obstetric indication. ACOG does support delivery prior to 39 weeks’ gestation, there just needs to be an appropriate indication.”