Testing fetal structural anomalies using simultaneous CNV-seq and whole-exome sequencing

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Key clinical point: The novel congenital anomaly testing strategy using simultaneous CNV-seq and whole-exome sequencing (WES) can effectively identify congenital defects and complex anomalies.

Major finding: Overall, 227 trios were identified with a causative alteration (CNV or variant), of which 84.14% were de novo. Both pathogenic CNVs and variants were identified in 10 fetuses. Multisystem anomalies yielded a higher diagnostic yield than single-system anomalies (32.28% vs 22.36%; P = .0183).

Study details: Findings are from a retrospective study of 1,800 pregnant women with singleton fetuses showing structural anomalies at prenatal ultrasound screening, of which 959 trios underwent simultaneous CNV-seq and WES analysis.

Disclosures: This study was funded by CAMS Innovation Fund for Medical Sciences, National Key R&D Program of China, and others. R Chen, X Zhang, C Liu, Y Li, and J Zhang declared being employees of Berry Genomics, and the other authors had no competing interests.

Source: Chen X et al. J Transl Med. 2022 Jan 3. doi: 10.1186/s12967-021-03202-9.

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Key clinical point: The novel congenital anomaly testing strategy using simultaneous CNV-seq and whole-exome sequencing (WES) can effectively identify congenital defects and complex anomalies.

Major finding: Overall, 227 trios were identified with a causative alteration (CNV or variant), of which 84.14% were de novo. Both pathogenic CNVs and variants were identified in 10 fetuses. Multisystem anomalies yielded a higher diagnostic yield than single-system anomalies (32.28% vs 22.36%; P = .0183).

Study details: Findings are from a retrospective study of 1,800 pregnant women with singleton fetuses showing structural anomalies at prenatal ultrasound screening, of which 959 trios underwent simultaneous CNV-seq and WES analysis.

Disclosures: This study was funded by CAMS Innovation Fund for Medical Sciences, National Key R&D Program of China, and others. R Chen, X Zhang, C Liu, Y Li, and J Zhang declared being employees of Berry Genomics, and the other authors had no competing interests.

Source: Chen X et al. J Transl Med. 2022 Jan 3. doi: 10.1186/s12967-021-03202-9.

Key clinical point: The novel congenital anomaly testing strategy using simultaneous CNV-seq and whole-exome sequencing (WES) can effectively identify congenital defects and complex anomalies.

Major finding: Overall, 227 trios were identified with a causative alteration (CNV or variant), of which 84.14% were de novo. Both pathogenic CNVs and variants were identified in 10 fetuses. Multisystem anomalies yielded a higher diagnostic yield than single-system anomalies (32.28% vs 22.36%; P = .0183).

Study details: Findings are from a retrospective study of 1,800 pregnant women with singleton fetuses showing structural anomalies at prenatal ultrasound screening, of which 959 trios underwent simultaneous CNV-seq and WES analysis.

Disclosures: This study was funded by CAMS Innovation Fund for Medical Sciences, National Key R&D Program of China, and others. R Chen, X Zhang, C Liu, Y Li, and J Zhang declared being employees of Berry Genomics, and the other authors had no competing interests.

Source: Chen X et al. J Transl Med. 2022 Jan 3. doi: 10.1186/s12967-021-03202-9.

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Rapid intrapartum test for maternal GBS colonization fails to reduce rate of antibiotics administered

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Mon, 01/24/2022 - 13:27

Key clinical point: Intrapartum rapid test to diagnose maternal group B Streptococcus (GBS) colonization did not reduce rates of prophylactic antibiotics administered to at-risk mothers for preventing mother-to-child transmission of GBS infection compared with the usual care policy of offering antibiotics based on only risk factors.

Major finding: The proportion of women receiving intrapartum antibiotic prophylaxis to prevent neonatal early-onset GBS infection was not significantly different between units assigned to rapid intrapartum test vs usual care (41% vs 36%; adjusted relative risk, 1.16; 95% CI, 0.83-1.64).

Study details: Findings are from a parallel-group cluster-randomized trial including 20 maternity clinics that were randomly assigned to a strategy of an intrapartum rapid test to detect maternal GBS colonization (722 mothers; 749 babies) or usual care (906 mothers; 951 babies).

Disclosures: The GBS2 study was funded by the National Institute for Health Research, Health Technology Assessment programme. JP Daniel, J Plumb, and J Gray declared being grant holders, receiving support for attending conferences, summits, or workshops from various sources and being members of various committees.

Source: Daniels JP et al. BMC Med. 2022 Jan 14. doi: 10.1186/s12916-021-02202-2.

 

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Key clinical point: Intrapartum rapid test to diagnose maternal group B Streptococcus (GBS) colonization did not reduce rates of prophylactic antibiotics administered to at-risk mothers for preventing mother-to-child transmission of GBS infection compared with the usual care policy of offering antibiotics based on only risk factors.

Major finding: The proportion of women receiving intrapartum antibiotic prophylaxis to prevent neonatal early-onset GBS infection was not significantly different between units assigned to rapid intrapartum test vs usual care (41% vs 36%; adjusted relative risk, 1.16; 95% CI, 0.83-1.64).

Study details: Findings are from a parallel-group cluster-randomized trial including 20 maternity clinics that were randomly assigned to a strategy of an intrapartum rapid test to detect maternal GBS colonization (722 mothers; 749 babies) or usual care (906 mothers; 951 babies).

Disclosures: The GBS2 study was funded by the National Institute for Health Research, Health Technology Assessment programme. JP Daniel, J Plumb, and J Gray declared being grant holders, receiving support for attending conferences, summits, or workshops from various sources and being members of various committees.

Source: Daniels JP et al. BMC Med. 2022 Jan 14. doi: 10.1186/s12916-021-02202-2.

 

Key clinical point: Intrapartum rapid test to diagnose maternal group B Streptococcus (GBS) colonization did not reduce rates of prophylactic antibiotics administered to at-risk mothers for preventing mother-to-child transmission of GBS infection compared with the usual care policy of offering antibiotics based on only risk factors.

Major finding: The proportion of women receiving intrapartum antibiotic prophylaxis to prevent neonatal early-onset GBS infection was not significantly different between units assigned to rapid intrapartum test vs usual care (41% vs 36%; adjusted relative risk, 1.16; 95% CI, 0.83-1.64).

Study details: Findings are from a parallel-group cluster-randomized trial including 20 maternity clinics that were randomly assigned to a strategy of an intrapartum rapid test to detect maternal GBS colonization (722 mothers; 749 babies) or usual care (906 mothers; 951 babies).

Disclosures: The GBS2 study was funded by the National Institute for Health Research, Health Technology Assessment programme. JP Daniel, J Plumb, and J Gray declared being grant holders, receiving support for attending conferences, summits, or workshops from various sources and being members of various committees.

Source: Daniels JP et al. BMC Med. 2022 Jan 14. doi: 10.1186/s12916-021-02202-2.

 

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Crown-chin length to crown-rump length ratio could help screen skeletal dysplasia in first trimester

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Key clinical point: Increased fetal crown-chin length (CCL)/crown-rump length (CRL) ratio at 11-14 weeks’ gestation was significantly associated with an increased risk for skeletal dysplasia and could help screen the same in the first trimester.

Major finding: Of 16 fetuses with skeletal dysplasia, 62.5% had a CCL/CRL ratio above the 95th percentile, which when used as a cutoff yielded a detection rate, specificity, false-positive rate, and the positive likelihood ratio of 62.5%, 72.6%, 5.0%, and 17.5%, respectively.

Study details: Findings are from a retrospective study that compared CCL/CRL ratios on a first-trimester ultrasound examination in 418 normal fetuses with 154 fetuses affected by skeletal dysplasia.

Disclosures: No source of funding was declared. None of the other authors declared any conflict of interests.

Source: Li Y et al. J Ultrasound Med. 2022 Jan 3. doi: 10.1002/jum.15936.

 

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Key clinical point: Increased fetal crown-chin length (CCL)/crown-rump length (CRL) ratio at 11-14 weeks’ gestation was significantly associated with an increased risk for skeletal dysplasia and could help screen the same in the first trimester.

Major finding: Of 16 fetuses with skeletal dysplasia, 62.5% had a CCL/CRL ratio above the 95th percentile, which when used as a cutoff yielded a detection rate, specificity, false-positive rate, and the positive likelihood ratio of 62.5%, 72.6%, 5.0%, and 17.5%, respectively.

Study details: Findings are from a retrospective study that compared CCL/CRL ratios on a first-trimester ultrasound examination in 418 normal fetuses with 154 fetuses affected by skeletal dysplasia.

Disclosures: No source of funding was declared. None of the other authors declared any conflict of interests.

Source: Li Y et al. J Ultrasound Med. 2022 Jan 3. doi: 10.1002/jum.15936.

 

Key clinical point: Increased fetal crown-chin length (CCL)/crown-rump length (CRL) ratio at 11-14 weeks’ gestation was significantly associated with an increased risk for skeletal dysplasia and could help screen the same in the first trimester.

Major finding: Of 16 fetuses with skeletal dysplasia, 62.5% had a CCL/CRL ratio above the 95th percentile, which when used as a cutoff yielded a detection rate, specificity, false-positive rate, and the positive likelihood ratio of 62.5%, 72.6%, 5.0%, and 17.5%, respectively.

Study details: Findings are from a retrospective study that compared CCL/CRL ratios on a first-trimester ultrasound examination in 418 normal fetuses with 154 fetuses affected by skeletal dysplasia.

Disclosures: No source of funding was declared. None of the other authors declared any conflict of interests.

Source: Li Y et al. J Ultrasound Med. 2022 Jan 3. doi: 10.1002/jum.15936.

 

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Fetal abdominal overgrowth already present at 20-24 gestational weeks in high-risk women with GDM

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Key clinical point: Fetal abdominal obesity (FAO) was already present at 20-24 gestational weeks (GW) in the high-risk older and/or obese women with gestational diabetes mellitus (GDM) with FAO at 20-24 GW in women with GDM being associated with higher odds of FAO at GDM diagnosis.

Major finding: Compared with normal glucose tolerance (NGT), older and/or obese women (P < .05) but not young and nonobese women with GDM had a significantly higher fetal abdominal overgrowth ratio at gestational weeks 20-24. Compared with NGT women without FAO at 20-24 GW, the odds ratio for exhibiting FAO at GDM diagnosis was 10.15 (95% CI, 5.27-19.57).

Study details: Findings are from a retrospective review of 6,996 singleton pregnant women who had fetal biometry data measured at 20-24 GW and delivered at the respective medical center were included.

Disclosures: The authors did not declare any source of funding. The authors declared no competing interests.

Source: Kim W et al. Sci Rep. 2021 Dec 10. doi: 10.1038/s41598-021-03145-7.

 

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Key clinical point: Fetal abdominal obesity (FAO) was already present at 20-24 gestational weeks (GW) in the high-risk older and/or obese women with gestational diabetes mellitus (GDM) with FAO at 20-24 GW in women with GDM being associated with higher odds of FAO at GDM diagnosis.

Major finding: Compared with normal glucose tolerance (NGT), older and/or obese women (P < .05) but not young and nonobese women with GDM had a significantly higher fetal abdominal overgrowth ratio at gestational weeks 20-24. Compared with NGT women without FAO at 20-24 GW, the odds ratio for exhibiting FAO at GDM diagnosis was 10.15 (95% CI, 5.27-19.57).

Study details: Findings are from a retrospective review of 6,996 singleton pregnant women who had fetal biometry data measured at 20-24 GW and delivered at the respective medical center were included.

Disclosures: The authors did not declare any source of funding. The authors declared no competing interests.

Source: Kim W et al. Sci Rep. 2021 Dec 10. doi: 10.1038/s41598-021-03145-7.

 

Key clinical point: Fetal abdominal obesity (FAO) was already present at 20-24 gestational weeks (GW) in the high-risk older and/or obese women with gestational diabetes mellitus (GDM) with FAO at 20-24 GW in women with GDM being associated with higher odds of FAO at GDM diagnosis.

Major finding: Compared with normal glucose tolerance (NGT), older and/or obese women (P < .05) but not young and nonobese women with GDM had a significantly higher fetal abdominal overgrowth ratio at gestational weeks 20-24. Compared with NGT women without FAO at 20-24 GW, the odds ratio for exhibiting FAO at GDM diagnosis was 10.15 (95% CI, 5.27-19.57).

Study details: Findings are from a retrospective review of 6,996 singleton pregnant women who had fetal biometry data measured at 20-24 GW and delivered at the respective medical center were included.

Disclosures: The authors did not declare any source of funding. The authors declared no competing interests.

Source: Kim W et al. Sci Rep. 2021 Dec 10. doi: 10.1038/s41598-021-03145-7.

 

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Growth-restricted fetuses have smaller cardiovascular biometrics already in mid-trimester of pregnancy

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Key clinical point: Fetuses classified postnatally as small for gestational age (SGA) and fetal growth restricted (FGR) had smaller prenatal cardiovascular biometrics already at the second trimester anatomy scan.

Major finding: Compared with the control fetus, the SGA group had significantly smaller ascending aorta in the 3-vessel view, whereas the FGR group had significantly smaller aortic valve and pulmonary valve, even after adjusting for gestational age and abdominal circumference (all P < .005).

Study details: Findings are from a sub-study of Copenhagen Baby Heart Study, a prospective study, including 8,278 fetuses from the second trimester of pregnancy, of which 625 were classified as SGA and 289 as FGR postnatally.

Disclosures: The study was supported by funding from “Rigshospitalets Research Foundation” and “Aase and EjnarDanielsens Research Foundation” received by C Vedel. OB Petersen declared holding a professorship funded by the Novo Nordisk Foundation. None of the other authors declared any conflict of interests.

Source: Frandsen JS et al. Am J Obstet Gynecol. 2021 Dec 20. doi: 10.1016/j.ajog.2021.12.031.

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Key clinical point: Fetuses classified postnatally as small for gestational age (SGA) and fetal growth restricted (FGR) had smaller prenatal cardiovascular biometrics already at the second trimester anatomy scan.

Major finding: Compared with the control fetus, the SGA group had significantly smaller ascending aorta in the 3-vessel view, whereas the FGR group had significantly smaller aortic valve and pulmonary valve, even after adjusting for gestational age and abdominal circumference (all P < .005).

Study details: Findings are from a sub-study of Copenhagen Baby Heart Study, a prospective study, including 8,278 fetuses from the second trimester of pregnancy, of which 625 were classified as SGA and 289 as FGR postnatally.

Disclosures: The study was supported by funding from “Rigshospitalets Research Foundation” and “Aase and EjnarDanielsens Research Foundation” received by C Vedel. OB Petersen declared holding a professorship funded by the Novo Nordisk Foundation. None of the other authors declared any conflict of interests.

Source: Frandsen JS et al. Am J Obstet Gynecol. 2021 Dec 20. doi: 10.1016/j.ajog.2021.12.031.

Key clinical point: Fetuses classified postnatally as small for gestational age (SGA) and fetal growth restricted (FGR) had smaller prenatal cardiovascular biometrics already at the second trimester anatomy scan.

Major finding: Compared with the control fetus, the SGA group had significantly smaller ascending aorta in the 3-vessel view, whereas the FGR group had significantly smaller aortic valve and pulmonary valve, even after adjusting for gestational age and abdominal circumference (all P < .005).

Study details: Findings are from a sub-study of Copenhagen Baby Heart Study, a prospective study, including 8,278 fetuses from the second trimester of pregnancy, of which 625 were classified as SGA and 289 as FGR postnatally.

Disclosures: The study was supported by funding from “Rigshospitalets Research Foundation” and “Aase and EjnarDanielsens Research Foundation” received by C Vedel. OB Petersen declared holding a professorship funded by the Novo Nordisk Foundation. None of the other authors declared any conflict of interests.

Source: Frandsen JS et al. Am J Obstet Gynecol. 2021 Dec 20. doi: 10.1016/j.ajog.2021.12.031.

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Trauma rates with operative vaginal delivery unexpectedly high, study finds

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A new investigation has found that rates of physical trauma following operative vaginal delivery (OVD) in Canada are higher than previously reported.

The cohort study of more than 1.3 million deliveries in the country found trauma rates were highest with forceps delivery, with more than 1 in 4 pregnancies resulting in maternal trauma and 1 in 105 infants experiencing neonatal trauma. Maternal and neonatal trauma following vacuum deliveries was less common, occurring in 1 in 8 pregnancies and 1 in 104 infants, according to the researchers, who reported their findings in the Canadian Medical Association Journal .

“The rates of trauma following OVD in Canada are higher than previously reported, irrespective of region, level of obstetric care, and volume of instrument use among hospitals,” lead author Giulia Muraca, PhD, MPH, assistant professor of obstetrics and gynecology at McMaster University, Hamilton, Ont., said in an interview. “While OVDs may be associated with low rates of morbidity in carefully selected circumstances, the uniformly high rates of trauma among forceps and vacuum deliveries documented across regions, levels of obstetric care, and hospitals show that such conditions do not apply to routine obstetric practice in Canada.”

The American College of Obstetricians and Gynecologists considers OVD a way to reduce the rate of cesarean deliveries. However, the group has also pointed to a decline in familiarity with the procedures among clinicians new to the field.

Current reports also show that while OVD accounts for up to 15% of deliveries in CanadaAustralia, and the United Kingdom, the risks associated with the approach are heavily dependent on the expertise of the provider. Declining use of OVD in favor of cesarean delivery has reduced opportunities for clinicians to acquire proficiency in performing these deliveries, according to the researchers.

Given these various factors, the investigators said the consensus on the safety of OVD is under scrutiny.

“An examination of maternal and neonatal trauma among OVD in contemporary practice is necessary to ensure that health care providers, policy makers, and pregnant individuals are informed regarding the risks of OVD typically experienced in routine obstetric practice, rather than those encountered under ideal conditions,” Dr. Muraca said.
 

Over 1 million deliveries studied

Dr. Muraca and colleagues looked at 1,326,191 deliveries occurring across Canada (except Quebec) between April 2013 and March 2019. The researchers included all singleton, term (≥37 weeks), in-hospital deliveries to women who had not undergone a previous cesarean delivery.

The study’s primary outcome measures were composite maternal trauma and composite neonatal trauma. Maternal trauma included obstetric anal sphincter injury (OASI); cervical or high vaginal laceration; pelvic hematoma; obstetric injury to the pelvic organs, pelvic joints, or ligaments; injury to the bladder or urethra; and other pelvic trauma. Neonatal trauma comprised intracranial hemorrhage and laceration, skull fracture, severe injury to the central or peripheral nervous system, fracture of the long bones, injury to the liver or spleen, seizures, and neonatal death.

The analysis found that 38,500 (2.9%) of the cases involved attempted forceps deliveries while 110,987 (8.4%) were attempted vacuum deliveries. Of the attempted forceps deliveries, 1,606 (4.2%) failed, while 8,791 (7.9%) of attempted vacuum deliveries failed.

Maternal trauma was observed in 25.3% of all forceps deliveries (n = 9,728) and 13.2% of all vacuum deliveries (n = 14,614), the researchers reported. The most common form of maternal trauma was OASI, which was observed in 21.52% of women undergoing forceps delivery and 11.67% of those undergoing vacuum delivery. The rates of all other forms of maternal trauma were higher among patients undergoing attempted forceps delivery than among their counterparts undergoing attempted vacuum delivery.

After adjusting for possible confounders, rates of maternal trauma remained higher with forceps than with vacuum deliveries (adjusted rate ratio, 1.70).

The rate of neonatal trauma was comparable for forceps (9.56/1,000 live births) and vacuum deliveries (9.58/1,000 live births). In these cases, damage to the peripheral nervous system was the most common form of neonatal trauma, occurring in 4.85/1,000 live births with forceps delivery and 3.41/1,000 live births for vacuum delivery, the researchers found.
 

 

 

Consider morbidity following OVD against potential alternatives, authors say

According to Dr. Muraca, the rates of maternal trauma in her study – along with accumulating evidence of the severe long-term consequences of these injuries – demonstrates the importance of reporting timely, empirically derived risk measures that accurately reflect those that pregnant individuals may encounter in typical obstetric practice.

“Although there is merit in understanding the estimates of risk that can be achieved when conditions are optimal, the interpretation of these estimates can be misleading, especially given secular shifts in patterns of practice,” she said. “The failure to do so compromises women’s autonomy in making evidence-informed decisions regarding childbirth interventions, such as evaluating the short- and long-term risks of OVD and cesarean delivery.

Her group recommended that morbidity following OVD be weighed against potential alternatives to such procedures, which carry their own risks. “This includes an extended second stage of labor and a spontaneous vaginal delivery, or a second-stage cesarean delivery, both of which are associated with significant morbidity,” Dr. Muraca said. “However, a comprehensive consideration of high population rates of OVD morbidity also prompts questions about choice of instrument, obstetrician training in OVD use, and for recognizing cases that would benefit from a cesarean delivery earlier in labor.”

Alan Peaceman, MD, professor of obstetrics and gynecology at Northwestern University, Chicago, said he was not surprised by the rates of sphincter injury, but that the rate of severe neonatal injury rate was higher than he expected. However, he added, “I don’t think clinicians should change their approach based on a single study. They should continue with the approach that they are most skilled at and is appropriate for the clinical circumstances.”

The study was funded by a grant from the Canadian Institutes of Health Research. Dr. Muraca and Dr. Peaceman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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A new investigation has found that rates of physical trauma following operative vaginal delivery (OVD) in Canada are higher than previously reported.

The cohort study of more than 1.3 million deliveries in the country found trauma rates were highest with forceps delivery, with more than 1 in 4 pregnancies resulting in maternal trauma and 1 in 105 infants experiencing neonatal trauma. Maternal and neonatal trauma following vacuum deliveries was less common, occurring in 1 in 8 pregnancies and 1 in 104 infants, according to the researchers, who reported their findings in the Canadian Medical Association Journal .

“The rates of trauma following OVD in Canada are higher than previously reported, irrespective of region, level of obstetric care, and volume of instrument use among hospitals,” lead author Giulia Muraca, PhD, MPH, assistant professor of obstetrics and gynecology at McMaster University, Hamilton, Ont., said in an interview. “While OVDs may be associated with low rates of morbidity in carefully selected circumstances, the uniformly high rates of trauma among forceps and vacuum deliveries documented across regions, levels of obstetric care, and hospitals show that such conditions do not apply to routine obstetric practice in Canada.”

The American College of Obstetricians and Gynecologists considers OVD a way to reduce the rate of cesarean deliveries. However, the group has also pointed to a decline in familiarity with the procedures among clinicians new to the field.

Current reports also show that while OVD accounts for up to 15% of deliveries in CanadaAustralia, and the United Kingdom, the risks associated with the approach are heavily dependent on the expertise of the provider. Declining use of OVD in favor of cesarean delivery has reduced opportunities for clinicians to acquire proficiency in performing these deliveries, according to the researchers.

Given these various factors, the investigators said the consensus on the safety of OVD is under scrutiny.

“An examination of maternal and neonatal trauma among OVD in contemporary practice is necessary to ensure that health care providers, policy makers, and pregnant individuals are informed regarding the risks of OVD typically experienced in routine obstetric practice, rather than those encountered under ideal conditions,” Dr. Muraca said.
 

Over 1 million deliveries studied

Dr. Muraca and colleagues looked at 1,326,191 deliveries occurring across Canada (except Quebec) between April 2013 and March 2019. The researchers included all singleton, term (≥37 weeks), in-hospital deliveries to women who had not undergone a previous cesarean delivery.

The study’s primary outcome measures were composite maternal trauma and composite neonatal trauma. Maternal trauma included obstetric anal sphincter injury (OASI); cervical or high vaginal laceration; pelvic hematoma; obstetric injury to the pelvic organs, pelvic joints, or ligaments; injury to the bladder or urethra; and other pelvic trauma. Neonatal trauma comprised intracranial hemorrhage and laceration, skull fracture, severe injury to the central or peripheral nervous system, fracture of the long bones, injury to the liver or spleen, seizures, and neonatal death.

The analysis found that 38,500 (2.9%) of the cases involved attempted forceps deliveries while 110,987 (8.4%) were attempted vacuum deliveries. Of the attempted forceps deliveries, 1,606 (4.2%) failed, while 8,791 (7.9%) of attempted vacuum deliveries failed.

Maternal trauma was observed in 25.3% of all forceps deliveries (n = 9,728) and 13.2% of all vacuum deliveries (n = 14,614), the researchers reported. The most common form of maternal trauma was OASI, which was observed in 21.52% of women undergoing forceps delivery and 11.67% of those undergoing vacuum delivery. The rates of all other forms of maternal trauma were higher among patients undergoing attempted forceps delivery than among their counterparts undergoing attempted vacuum delivery.

After adjusting for possible confounders, rates of maternal trauma remained higher with forceps than with vacuum deliveries (adjusted rate ratio, 1.70).

The rate of neonatal trauma was comparable for forceps (9.56/1,000 live births) and vacuum deliveries (9.58/1,000 live births). In these cases, damage to the peripheral nervous system was the most common form of neonatal trauma, occurring in 4.85/1,000 live births with forceps delivery and 3.41/1,000 live births for vacuum delivery, the researchers found.
 

 

 

Consider morbidity following OVD against potential alternatives, authors say

According to Dr. Muraca, the rates of maternal trauma in her study – along with accumulating evidence of the severe long-term consequences of these injuries – demonstrates the importance of reporting timely, empirically derived risk measures that accurately reflect those that pregnant individuals may encounter in typical obstetric practice.

“Although there is merit in understanding the estimates of risk that can be achieved when conditions are optimal, the interpretation of these estimates can be misleading, especially given secular shifts in patterns of practice,” she said. “The failure to do so compromises women’s autonomy in making evidence-informed decisions regarding childbirth interventions, such as evaluating the short- and long-term risks of OVD and cesarean delivery.

Her group recommended that morbidity following OVD be weighed against potential alternatives to such procedures, which carry their own risks. “This includes an extended second stage of labor and a spontaneous vaginal delivery, or a second-stage cesarean delivery, both of which are associated with significant morbidity,” Dr. Muraca said. “However, a comprehensive consideration of high population rates of OVD morbidity also prompts questions about choice of instrument, obstetrician training in OVD use, and for recognizing cases that would benefit from a cesarean delivery earlier in labor.”

Alan Peaceman, MD, professor of obstetrics and gynecology at Northwestern University, Chicago, said he was not surprised by the rates of sphincter injury, but that the rate of severe neonatal injury rate was higher than he expected. However, he added, “I don’t think clinicians should change their approach based on a single study. They should continue with the approach that they are most skilled at and is appropriate for the clinical circumstances.”

The study was funded by a grant from the Canadian Institutes of Health Research. Dr. Muraca and Dr. Peaceman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new investigation has found that rates of physical trauma following operative vaginal delivery (OVD) in Canada are higher than previously reported.

The cohort study of more than 1.3 million deliveries in the country found trauma rates were highest with forceps delivery, with more than 1 in 4 pregnancies resulting in maternal trauma and 1 in 105 infants experiencing neonatal trauma. Maternal and neonatal trauma following vacuum deliveries was less common, occurring in 1 in 8 pregnancies and 1 in 104 infants, according to the researchers, who reported their findings in the Canadian Medical Association Journal .

“The rates of trauma following OVD in Canada are higher than previously reported, irrespective of region, level of obstetric care, and volume of instrument use among hospitals,” lead author Giulia Muraca, PhD, MPH, assistant professor of obstetrics and gynecology at McMaster University, Hamilton, Ont., said in an interview. “While OVDs may be associated with low rates of morbidity in carefully selected circumstances, the uniformly high rates of trauma among forceps and vacuum deliveries documented across regions, levels of obstetric care, and hospitals show that such conditions do not apply to routine obstetric practice in Canada.”

The American College of Obstetricians and Gynecologists considers OVD a way to reduce the rate of cesarean deliveries. However, the group has also pointed to a decline in familiarity with the procedures among clinicians new to the field.

Current reports also show that while OVD accounts for up to 15% of deliveries in CanadaAustralia, and the United Kingdom, the risks associated with the approach are heavily dependent on the expertise of the provider. Declining use of OVD in favor of cesarean delivery has reduced opportunities for clinicians to acquire proficiency in performing these deliveries, according to the researchers.

Given these various factors, the investigators said the consensus on the safety of OVD is under scrutiny.

“An examination of maternal and neonatal trauma among OVD in contemporary practice is necessary to ensure that health care providers, policy makers, and pregnant individuals are informed regarding the risks of OVD typically experienced in routine obstetric practice, rather than those encountered under ideal conditions,” Dr. Muraca said.
 

Over 1 million deliveries studied

Dr. Muraca and colleagues looked at 1,326,191 deliveries occurring across Canada (except Quebec) between April 2013 and March 2019. The researchers included all singleton, term (≥37 weeks), in-hospital deliveries to women who had not undergone a previous cesarean delivery.

The study’s primary outcome measures were composite maternal trauma and composite neonatal trauma. Maternal trauma included obstetric anal sphincter injury (OASI); cervical or high vaginal laceration; pelvic hematoma; obstetric injury to the pelvic organs, pelvic joints, or ligaments; injury to the bladder or urethra; and other pelvic trauma. Neonatal trauma comprised intracranial hemorrhage and laceration, skull fracture, severe injury to the central or peripheral nervous system, fracture of the long bones, injury to the liver or spleen, seizures, and neonatal death.

The analysis found that 38,500 (2.9%) of the cases involved attempted forceps deliveries while 110,987 (8.4%) were attempted vacuum deliveries. Of the attempted forceps deliveries, 1,606 (4.2%) failed, while 8,791 (7.9%) of attempted vacuum deliveries failed.

Maternal trauma was observed in 25.3% of all forceps deliveries (n = 9,728) and 13.2% of all vacuum deliveries (n = 14,614), the researchers reported. The most common form of maternal trauma was OASI, which was observed in 21.52% of women undergoing forceps delivery and 11.67% of those undergoing vacuum delivery. The rates of all other forms of maternal trauma were higher among patients undergoing attempted forceps delivery than among their counterparts undergoing attempted vacuum delivery.

After adjusting for possible confounders, rates of maternal trauma remained higher with forceps than with vacuum deliveries (adjusted rate ratio, 1.70).

The rate of neonatal trauma was comparable for forceps (9.56/1,000 live births) and vacuum deliveries (9.58/1,000 live births). In these cases, damage to the peripheral nervous system was the most common form of neonatal trauma, occurring in 4.85/1,000 live births with forceps delivery and 3.41/1,000 live births for vacuum delivery, the researchers found.
 

 

 

Consider morbidity following OVD against potential alternatives, authors say

According to Dr. Muraca, the rates of maternal trauma in her study – along with accumulating evidence of the severe long-term consequences of these injuries – demonstrates the importance of reporting timely, empirically derived risk measures that accurately reflect those that pregnant individuals may encounter in typical obstetric practice.

“Although there is merit in understanding the estimates of risk that can be achieved when conditions are optimal, the interpretation of these estimates can be misleading, especially given secular shifts in patterns of practice,” she said. “The failure to do so compromises women’s autonomy in making evidence-informed decisions regarding childbirth interventions, such as evaluating the short- and long-term risks of OVD and cesarean delivery.

Her group recommended that morbidity following OVD be weighed against potential alternatives to such procedures, which carry their own risks. “This includes an extended second stage of labor and a spontaneous vaginal delivery, or a second-stage cesarean delivery, both of which are associated with significant morbidity,” Dr. Muraca said. “However, a comprehensive consideration of high population rates of OVD morbidity also prompts questions about choice of instrument, obstetrician training in OVD use, and for recognizing cases that would benefit from a cesarean delivery earlier in labor.”

Alan Peaceman, MD, professor of obstetrics and gynecology at Northwestern University, Chicago, said he was not surprised by the rates of sphincter injury, but that the rate of severe neonatal injury rate was higher than he expected. However, he added, “I don’t think clinicians should change their approach based on a single study. They should continue with the approach that they are most skilled at and is appropriate for the clinical circumstances.”

The study was funded by a grant from the Canadian Institutes of Health Research. Dr. Muraca and Dr. Peaceman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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FROM THE CANADIAN MEDICAL ASSOCIATION JOURNAL

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Advanced HCC: Data spanning 15 years shows significant improvement in clinical outcomes with sorafenib

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Key clinical point: Between 2005 and 2019, sorafenib therapy has led to improvement in clinical outcomes among treatment-naïve patients with advanced hepatocellular carcinoma (HCC) in concurrence with a decrease in the median duration of therapy.

Main finding: While the median duration of therapy decreased by 53%, from 23.1 weeks to 12.2 weeks (P = .003) over the study period, the median overall survival increased by 4.5 months (P = .048) and the objective response rate increased by 6 months (P = .003).

Study details: This was an analysis of 16 randomized clinical trials (9 phase 3 and 7 phase 2) conducted from 2005-2019, wherein sorafenib was administered to 4,086 patients with advanced HCC naïve to systemic therapy to compare its effect relative to another systemic therapy or placebo.

Disclosures: The study received grants from the National Institutes of Health. M Yarchoan declared receiving research grants from or working as a consultant for various organizations.

Source: Brown TJ et al. Gastrointest Tumors. 2021 Dec 22. doi: 10.1159/000521625.

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Key clinical point: Between 2005 and 2019, sorafenib therapy has led to improvement in clinical outcomes among treatment-naïve patients with advanced hepatocellular carcinoma (HCC) in concurrence with a decrease in the median duration of therapy.

Main finding: While the median duration of therapy decreased by 53%, from 23.1 weeks to 12.2 weeks (P = .003) over the study period, the median overall survival increased by 4.5 months (P = .048) and the objective response rate increased by 6 months (P = .003).

Study details: This was an analysis of 16 randomized clinical trials (9 phase 3 and 7 phase 2) conducted from 2005-2019, wherein sorafenib was administered to 4,086 patients with advanced HCC naïve to systemic therapy to compare its effect relative to another systemic therapy or placebo.

Disclosures: The study received grants from the National Institutes of Health. M Yarchoan declared receiving research grants from or working as a consultant for various organizations.

Source: Brown TJ et al. Gastrointest Tumors. 2021 Dec 22. doi: 10.1159/000521625.

Key clinical point: Between 2005 and 2019, sorafenib therapy has led to improvement in clinical outcomes among treatment-naïve patients with advanced hepatocellular carcinoma (HCC) in concurrence with a decrease in the median duration of therapy.

Main finding: While the median duration of therapy decreased by 53%, from 23.1 weeks to 12.2 weeks (P = .003) over the study period, the median overall survival increased by 4.5 months (P = .048) and the objective response rate increased by 6 months (P = .003).

Study details: This was an analysis of 16 randomized clinical trials (9 phase 3 and 7 phase 2) conducted from 2005-2019, wherein sorafenib was administered to 4,086 patients with advanced HCC naïve to systemic therapy to compare its effect relative to another systemic therapy or placebo.

Disclosures: The study received grants from the National Institutes of Health. M Yarchoan declared receiving research grants from or working as a consultant for various organizations.

Source: Brown TJ et al. Gastrointest Tumors. 2021 Dec 22. doi: 10.1159/000521625.

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How can the patient response and outcome to drug-eluting bead TACE for HCC be predicted?

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Key clinical point: Having undergone drug-eluting bead transarterial chemoembolization (DEB-TACE), treatment response and disease-free survival (DFS) in patients with hepatocellular carcinoma (HCC) could be predicted by MRI signal intensity in the hepatobiliary phase (HBP) and serum alpha-fetoprotein (AFP) levels, respectively.

Main finding: The only significant predictive factors of noncomplete response and short DFS were signal intensity heterogeneity in the HBP (adjusted odds ratio, 4.807; P = .048) and elevated serum AFP levels (≥30 ng/mL; adjusted hazard ratio, 2.916; P = .040), respectively.

Study details: This was a preliminary single-center retrospective study including 55 treatment-naive patients who underwent DEB-TACE for HCC.

Disclosures: The study was sponsored by the Bio & Medical Technology Development Program of the National Research Foundation funded by the Korean government. The authors reported no conflict of interests.

Source: Lee JY et al. Sci Rep. 2021 Dec 15. doi: 10.1038/s41598-021-01839-6.

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Key clinical point: Having undergone drug-eluting bead transarterial chemoembolization (DEB-TACE), treatment response and disease-free survival (DFS) in patients with hepatocellular carcinoma (HCC) could be predicted by MRI signal intensity in the hepatobiliary phase (HBP) and serum alpha-fetoprotein (AFP) levels, respectively.

Main finding: The only significant predictive factors of noncomplete response and short DFS were signal intensity heterogeneity in the HBP (adjusted odds ratio, 4.807; P = .048) and elevated serum AFP levels (≥30 ng/mL; adjusted hazard ratio, 2.916; P = .040), respectively.

Study details: This was a preliminary single-center retrospective study including 55 treatment-naive patients who underwent DEB-TACE for HCC.

Disclosures: The study was sponsored by the Bio & Medical Technology Development Program of the National Research Foundation funded by the Korean government. The authors reported no conflict of interests.

Source: Lee JY et al. Sci Rep. 2021 Dec 15. doi: 10.1038/s41598-021-01839-6.

Key clinical point: Having undergone drug-eluting bead transarterial chemoembolization (DEB-TACE), treatment response and disease-free survival (DFS) in patients with hepatocellular carcinoma (HCC) could be predicted by MRI signal intensity in the hepatobiliary phase (HBP) and serum alpha-fetoprotein (AFP) levels, respectively.

Main finding: The only significant predictive factors of noncomplete response and short DFS were signal intensity heterogeneity in the HBP (adjusted odds ratio, 4.807; P = .048) and elevated serum AFP levels (≥30 ng/mL; adjusted hazard ratio, 2.916; P = .040), respectively.

Study details: This was a preliminary single-center retrospective study including 55 treatment-naive patients who underwent DEB-TACE for HCC.

Disclosures: The study was sponsored by the Bio & Medical Technology Development Program of the National Research Foundation funded by the Korean government. The authors reported no conflict of interests.

Source: Lee JY et al. Sci Rep. 2021 Dec 15. doi: 10.1038/s41598-021-01839-6.

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Microwave ablation as a possible real-world replacement for radiofrequency ablation in HCC

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Key clinical point: Compared with radiofrequency ablation (RFA), microwave ablation (MWA) effectuates better 1- and 2-year disease-free survival (DFS) along with a lower risk of major complications in patients with hepatocellular carcinoma (HCC).

Main finding: Although both ablation therapies led to a similar 2-year overall survival (P = .573), MWA achieved better 1-year DFS (79.7% vs 60.7%; P = .035) and 2-year DFS (72.5% vs 45.4%; P = .02) rates than RFA. Concurrently, MWA showed a lower rate of major complications than RFA (14% vs 29%; P = .043).

Study details: Findings are from a retrospective cohort study involving 150 patients with HCC, including treatment-naïve and recurrent HCC, who were treated with either RFA (n=100) or MWA (n=50).

Disclosures: The study was sponsored by the Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education. No conflict of interests was reported by the authors.

Source: Lee SK et al. J Clin Med. 2022 Jan 7. doi: 10.3390/jcm11020302.

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Key clinical point: Compared with radiofrequency ablation (RFA), microwave ablation (MWA) effectuates better 1- and 2-year disease-free survival (DFS) along with a lower risk of major complications in patients with hepatocellular carcinoma (HCC).

Main finding: Although both ablation therapies led to a similar 2-year overall survival (P = .573), MWA achieved better 1-year DFS (79.7% vs 60.7%; P = .035) and 2-year DFS (72.5% vs 45.4%; P = .02) rates than RFA. Concurrently, MWA showed a lower rate of major complications than RFA (14% vs 29%; P = .043).

Study details: Findings are from a retrospective cohort study involving 150 patients with HCC, including treatment-naïve and recurrent HCC, who were treated with either RFA (n=100) or MWA (n=50).

Disclosures: The study was sponsored by the Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education. No conflict of interests was reported by the authors.

Source: Lee SK et al. J Clin Med. 2022 Jan 7. doi: 10.3390/jcm11020302.

Key clinical point: Compared with radiofrequency ablation (RFA), microwave ablation (MWA) effectuates better 1- and 2-year disease-free survival (DFS) along with a lower risk of major complications in patients with hepatocellular carcinoma (HCC).

Main finding: Although both ablation therapies led to a similar 2-year overall survival (P = .573), MWA achieved better 1-year DFS (79.7% vs 60.7%; P = .035) and 2-year DFS (72.5% vs 45.4%; P = .02) rates than RFA. Concurrently, MWA showed a lower rate of major complications than RFA (14% vs 29%; P = .043).

Study details: Findings are from a retrospective cohort study involving 150 patients with HCC, including treatment-naïve and recurrent HCC, who were treated with either RFA (n=100) or MWA (n=50).

Disclosures: The study was sponsored by the Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education. No conflict of interests was reported by the authors.

Source: Lee SK et al. J Clin Med. 2022 Jan 7. doi: 10.3390/jcm11020302.

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Periportal HCC: Long-term outcome of radiofrequency ablation

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Key clinical point: First-line radiofrequency ablation (RFA) is associated with worse long-term therapeutic outcomes for single periportal hepatocellular carcinoma (HCC) than for single nonperiportal HCC.

Main finding: At 1 and 5 years, periportal vs nonperiportal HCC was associated with significantly higher local tumor progression rates (15.7% and 46.9% vs 6.0% and 28.7%, respectively; P = .007) and worse overall survival rates (81.3% and 42.9% vs 99.3% and 78.1%, respectively; P < .0001).

Study details: The data come from a retrospective study involving 233 patients with HCC, either periportal (n=56) or nonperiportal (n=177), who underwent percutaneous RFA alone or combined with transarterial chemoembolization as first-line treatment.

Disclosures: The authors reported no funding source or conflict of interests.

Source: Cao S et al. Cancer Imaging. 2022 Jan 4. doi: 10.1186/s40644-021-00442-2.

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Key clinical point: First-line radiofrequency ablation (RFA) is associated with worse long-term therapeutic outcomes for single periportal hepatocellular carcinoma (HCC) than for single nonperiportal HCC.

Main finding: At 1 and 5 years, periportal vs nonperiportal HCC was associated with significantly higher local tumor progression rates (15.7% and 46.9% vs 6.0% and 28.7%, respectively; P = .007) and worse overall survival rates (81.3% and 42.9% vs 99.3% and 78.1%, respectively; P < .0001).

Study details: The data come from a retrospective study involving 233 patients with HCC, either periportal (n=56) or nonperiportal (n=177), who underwent percutaneous RFA alone or combined with transarterial chemoembolization as first-line treatment.

Disclosures: The authors reported no funding source or conflict of interests.

Source: Cao S et al. Cancer Imaging. 2022 Jan 4. doi: 10.1186/s40644-021-00442-2.

Key clinical point: First-line radiofrequency ablation (RFA) is associated with worse long-term therapeutic outcomes for single periportal hepatocellular carcinoma (HCC) than for single nonperiportal HCC.

Main finding: At 1 and 5 years, periportal vs nonperiportal HCC was associated with significantly higher local tumor progression rates (15.7% and 46.9% vs 6.0% and 28.7%, respectively; P = .007) and worse overall survival rates (81.3% and 42.9% vs 99.3% and 78.1%, respectively; P < .0001).

Study details: The data come from a retrospective study involving 233 patients with HCC, either periportal (n=56) or nonperiportal (n=177), who underwent percutaneous RFA alone or combined with transarterial chemoembolization as first-line treatment.

Disclosures: The authors reported no funding source or conflict of interests.

Source: Cao S et al. Cancer Imaging. 2022 Jan 4. doi: 10.1186/s40644-021-00442-2.

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