Gabapentin helpful for hot flushes in postmenopausal women

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Gabapentin helpful for hot flushes in postmenopausal women
PRACTICE RECOMMENDATIONS

Gabapentin effectively decreases both the frequency and severity of hot flushes in postmenopausal women who report 7 or more hot flushes per day. Gabapentin, an anticonvulsant, is indicated by the US Food and Drug Administration as adjunct therapy in the treatment of partial seizures in epilepsy.

Although somnolence, dizziness, and peripheral edema are commonly experienced by patients taking this medication, gabapentin provides an effective treatment for reducing the number of hot flushes in women for whom hormone replacement therapy (HRT) is not recommended or desired.

 
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Guttuso T, Kurlan R, McDermott MP, Kieburtz K. Gabapentin’s effects on hot flashes in postmenopausal women: A randomized controlled trial. Obstet Gynecol 2003; 101:337–345.

Christopher Haines, MD, MA
Marc I. Harwood, MD
Department of Family Medicine, Thomas Jefferson University Hospital, Philadelphia, Pa.

[email protected].

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Guttuso T, Kurlan R, McDermott MP, Kieburtz K. Gabapentin’s effects on hot flashes in postmenopausal women: A randomized controlled trial. Obstet Gynecol 2003; 101:337–345.

Christopher Haines, MD, MA
Marc I. Harwood, MD
Department of Family Medicine, Thomas Jefferson University Hospital, Philadelphia, Pa.

[email protected].

Author and Disclosure Information

Practice Recommendations from Key Studies

Guttuso T, Kurlan R, McDermott MP, Kieburtz K. Gabapentin’s effects on hot flashes in postmenopausal women: A randomized controlled trial. Obstet Gynecol 2003; 101:337–345.

Christopher Haines, MD, MA
Marc I. Harwood, MD
Department of Family Medicine, Thomas Jefferson University Hospital, Philadelphia, Pa.

[email protected].

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PRACTICE RECOMMENDATIONS

Gabapentin effectively decreases both the frequency and severity of hot flushes in postmenopausal women who report 7 or more hot flushes per day. Gabapentin, an anticonvulsant, is indicated by the US Food and Drug Administration as adjunct therapy in the treatment of partial seizures in epilepsy.

Although somnolence, dizziness, and peripheral edema are commonly experienced by patients taking this medication, gabapentin provides an effective treatment for reducing the number of hot flushes in women for whom hormone replacement therapy (HRT) is not recommended or desired.

 
PRACTICE RECOMMENDATIONS

Gabapentin effectively decreases both the frequency and severity of hot flushes in postmenopausal women who report 7 or more hot flushes per day. Gabapentin, an anticonvulsant, is indicated by the US Food and Drug Administration as adjunct therapy in the treatment of partial seizures in epilepsy.

Although somnolence, dizziness, and peripheral edema are commonly experienced by patients taking this medication, gabapentin provides an effective treatment for reducing the number of hot flushes in women for whom hormone replacement therapy (HRT) is not recommended or desired.

 
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Gabapentin helpful for hot flushes in postmenopausal women
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What is the most effective treatment for acute low back pain?

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What is the most effective treatment for acute low back pain?
EVIDENCE-BASED ANSWER

Nonsteroidal anti inflammatory drugs (NSAIDs) are more effective than placebo for pain relief in patients with acute low back pain (grade of recommendation: A). There is no consistent evidence that NSAIDs are more effective than acetaminophen (grade: D). Muscle relaxants are effective for short-term relief of acute low back pain (grade: A), but there is no added benefit when they are used in combination with NSAIDs (grade: B). Advice to remain active speeds recovery compared with short-term bed rest (grade: A). There is no consistent evidence that epidural steroid injections are effective for acute low back pain (grade: D). Spinal manipulation or back exercises are no more effective than medications alone (grade: B).

Evidence summary

A recent systematic review found NSAIDs more effective than placebo for pain relief in patients with acute low back pain.1 There is conflicting evidence regarding the effectiveness of NSAIDs versus acetaminophen or narcotics alone.

According to another systematic review, there is no difference in pain intensity at 3 weeks’ follow-up between active patients and patients for whom variable lengths of short-term bed rest for treatment of acute low back pain have been prescribed.2 No consistent conclusions could be drawn regarding the effectiveness of epidural steroid injections for acute low back pain.3 This analysis was limited by the inclusion of all studies of patients with acute low back pain regardless of the underlying etiology and presence or absence of radicular symptoms. A systematic review of 12 trials reported inconsistent results of facet joint, epidural, and local corticosteroid injections; however, only 1 studied epidural injections.4

 

Cyclobenzaprine is more effective than placebo, according to a recent systematic review summary (odds ratio for improvement by day 10: 4.7 [2.7-8.1 95% CI]; number needed to treat [NNT] = 2.7 [2.0-4.2 95% CI]).5 There is no statistically significant difference in pain relief between patients using NSAIDs alone versus those using both NSAIDs and muscle relaxants.1 The use of muscle relaxants was associated with more adverse reactions than placebo (53% vs 28%; number needed to harm [NNH] = 4).

Performance of specific flexion or extension exercises was no more effective than analgesics.6 In a randomized, controlled trial (n = 321) to assess the effectiveness of formal physical therapy for acute low back pain, patients referred to physical therapy were more satisfied with their care than were patients given handouts on back exercises, even though disability and pain scores were unchanged.7 Evidence is insufficient to support the use of spinal manipulation in patients with acute low back pain because of serious design flaws in the trials.8

Recommendations from others

The Institute for Clinical Systems Improvement recommends conservative treatment such as cold and heat therapies and over-the-counter anti-inflammatory or analgesic drugs as the first line of treatment. Patients with acute low back pain should stay active and continue routine activity within the limits permitted by the pain.9 The Agency for Health Care Policy and Research states that acetaminophen is the treatment of choice for low back pain and that NSAIDs should be used sparingly because of their potential side effects. Manipulation is safe and effective in the first month in patients who do not have radicular symptoms.10

CLINICAL COMMENTARY

Sang-ick Chang, MD
Department of Family and Community Medicine UCSF School of Medicine

My recent practice has been to greatly liberalize the use of opiates in the acute situation. With close phone and office follow-up, it is possible to do better than to provide reassurance alone. That the patient does not have surgical disease and will eventually improve should not obscure our obligation to relieve the acute pain. Muscle relaxants such as cyclobenzaprine may function primarily as a sedative, although they too may have a useful role.

References

1. van Tulder MW, Scholten RJ, Koes BW, Deyo RA. Cochrane Database Syst Rev 2000;2.-

2. Hagen KB, Hilde G, Jamtvedt G, Winnem M. Cochrane Syst Rev 2000;2.-

3. Rozenberg S, Dubourg G, Khalifa P, Paolozzi L, Maheu E, Ravaud P. Rev Rheum Engl Ed 1999;66:79-85.

4. Koes BW, Scholten RJ, Men JM, Bouter LM. Pain 1995;63:279-88.

5. Browning R, Jackson JL, O’Malley PG. Arch Intern Med 2001;161:1613-20.

6. Faas A. Spine 1996;21:2874-8.

7. Cherkin DC, Deyo RA, Battie M, et al. N Engl J Med 1998;339:1021-9.

8. Assendelft WJJ, Koes BW, van der Heijden GJMG, Bouter LM. J Manipulative Physiol Ther 1996;19:499-507.

9. Institute for Clinical Systems Improvement (ICSI). ICSI health care guidelines no. GMS01. Bloomington, Minn: November 1999.

10. Bigos S, Bowyer O, Braen G, et al. AHCPR publication 95-0642, 1994.

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Literature search by Leilani St. Anna, MLS

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Sports Medicine Fellowship Department of Family Medicine Thomas Jefferson University Hospital Philadelphia, Pennsylvania
Literature search by Leilani St. Anna, MLS

Article PDF
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EVIDENCE-BASED ANSWER

Nonsteroidal anti inflammatory drugs (NSAIDs) are more effective than placebo for pain relief in patients with acute low back pain (grade of recommendation: A). There is no consistent evidence that NSAIDs are more effective than acetaminophen (grade: D). Muscle relaxants are effective for short-term relief of acute low back pain (grade: A), but there is no added benefit when they are used in combination with NSAIDs (grade: B). Advice to remain active speeds recovery compared with short-term bed rest (grade: A). There is no consistent evidence that epidural steroid injections are effective for acute low back pain (grade: D). Spinal manipulation or back exercises are no more effective than medications alone (grade: B).

Evidence summary

A recent systematic review found NSAIDs more effective than placebo for pain relief in patients with acute low back pain.1 There is conflicting evidence regarding the effectiveness of NSAIDs versus acetaminophen or narcotics alone.

According to another systematic review, there is no difference in pain intensity at 3 weeks’ follow-up between active patients and patients for whom variable lengths of short-term bed rest for treatment of acute low back pain have been prescribed.2 No consistent conclusions could be drawn regarding the effectiveness of epidural steroid injections for acute low back pain.3 This analysis was limited by the inclusion of all studies of patients with acute low back pain regardless of the underlying etiology and presence or absence of radicular symptoms. A systematic review of 12 trials reported inconsistent results of facet joint, epidural, and local corticosteroid injections; however, only 1 studied epidural injections.4

 

Cyclobenzaprine is more effective than placebo, according to a recent systematic review summary (odds ratio for improvement by day 10: 4.7 [2.7-8.1 95% CI]; number needed to treat [NNT] = 2.7 [2.0-4.2 95% CI]).5 There is no statistically significant difference in pain relief between patients using NSAIDs alone versus those using both NSAIDs and muscle relaxants.1 The use of muscle relaxants was associated with more adverse reactions than placebo (53% vs 28%; number needed to harm [NNH] = 4).

Performance of specific flexion or extension exercises was no more effective than analgesics.6 In a randomized, controlled trial (n = 321) to assess the effectiveness of formal physical therapy for acute low back pain, patients referred to physical therapy were more satisfied with their care than were patients given handouts on back exercises, even though disability and pain scores were unchanged.7 Evidence is insufficient to support the use of spinal manipulation in patients with acute low back pain because of serious design flaws in the trials.8

Recommendations from others

The Institute for Clinical Systems Improvement recommends conservative treatment such as cold and heat therapies and over-the-counter anti-inflammatory or analgesic drugs as the first line of treatment. Patients with acute low back pain should stay active and continue routine activity within the limits permitted by the pain.9 The Agency for Health Care Policy and Research states that acetaminophen is the treatment of choice for low back pain and that NSAIDs should be used sparingly because of their potential side effects. Manipulation is safe and effective in the first month in patients who do not have radicular symptoms.10

CLINICAL COMMENTARY

Sang-ick Chang, MD
Department of Family and Community Medicine UCSF School of Medicine

My recent practice has been to greatly liberalize the use of opiates in the acute situation. With close phone and office follow-up, it is possible to do better than to provide reassurance alone. That the patient does not have surgical disease and will eventually improve should not obscure our obligation to relieve the acute pain. Muscle relaxants such as cyclobenzaprine may function primarily as a sedative, although they too may have a useful role.

EVIDENCE-BASED ANSWER

Nonsteroidal anti inflammatory drugs (NSAIDs) are more effective than placebo for pain relief in patients with acute low back pain (grade of recommendation: A). There is no consistent evidence that NSAIDs are more effective than acetaminophen (grade: D). Muscle relaxants are effective for short-term relief of acute low back pain (grade: A), but there is no added benefit when they are used in combination with NSAIDs (grade: B). Advice to remain active speeds recovery compared with short-term bed rest (grade: A). There is no consistent evidence that epidural steroid injections are effective for acute low back pain (grade: D). Spinal manipulation or back exercises are no more effective than medications alone (grade: B).

Evidence summary

A recent systematic review found NSAIDs more effective than placebo for pain relief in patients with acute low back pain.1 There is conflicting evidence regarding the effectiveness of NSAIDs versus acetaminophen or narcotics alone.

According to another systematic review, there is no difference in pain intensity at 3 weeks’ follow-up between active patients and patients for whom variable lengths of short-term bed rest for treatment of acute low back pain have been prescribed.2 No consistent conclusions could be drawn regarding the effectiveness of epidural steroid injections for acute low back pain.3 This analysis was limited by the inclusion of all studies of patients with acute low back pain regardless of the underlying etiology and presence or absence of radicular symptoms. A systematic review of 12 trials reported inconsistent results of facet joint, epidural, and local corticosteroid injections; however, only 1 studied epidural injections.4

 

Cyclobenzaprine is more effective than placebo, according to a recent systematic review summary (odds ratio for improvement by day 10: 4.7 [2.7-8.1 95% CI]; number needed to treat [NNT] = 2.7 [2.0-4.2 95% CI]).5 There is no statistically significant difference in pain relief between patients using NSAIDs alone versus those using both NSAIDs and muscle relaxants.1 The use of muscle relaxants was associated with more adverse reactions than placebo (53% vs 28%; number needed to harm [NNH] = 4).

Performance of specific flexion or extension exercises was no more effective than analgesics.6 In a randomized, controlled trial (n = 321) to assess the effectiveness of formal physical therapy for acute low back pain, patients referred to physical therapy were more satisfied with their care than were patients given handouts on back exercises, even though disability and pain scores were unchanged.7 Evidence is insufficient to support the use of spinal manipulation in patients with acute low back pain because of serious design flaws in the trials.8

Recommendations from others

The Institute for Clinical Systems Improvement recommends conservative treatment such as cold and heat therapies and over-the-counter anti-inflammatory or analgesic drugs as the first line of treatment. Patients with acute low back pain should stay active and continue routine activity within the limits permitted by the pain.9 The Agency for Health Care Policy and Research states that acetaminophen is the treatment of choice for low back pain and that NSAIDs should be used sparingly because of their potential side effects. Manipulation is safe and effective in the first month in patients who do not have radicular symptoms.10

CLINICAL COMMENTARY

Sang-ick Chang, MD
Department of Family and Community Medicine UCSF School of Medicine

My recent practice has been to greatly liberalize the use of opiates in the acute situation. With close phone and office follow-up, it is possible to do better than to provide reassurance alone. That the patient does not have surgical disease and will eventually improve should not obscure our obligation to relieve the acute pain. Muscle relaxants such as cyclobenzaprine may function primarily as a sedative, although they too may have a useful role.

References

1. van Tulder MW, Scholten RJ, Koes BW, Deyo RA. Cochrane Database Syst Rev 2000;2.-

2. Hagen KB, Hilde G, Jamtvedt G, Winnem M. Cochrane Syst Rev 2000;2.-

3. Rozenberg S, Dubourg G, Khalifa P, Paolozzi L, Maheu E, Ravaud P. Rev Rheum Engl Ed 1999;66:79-85.

4. Koes BW, Scholten RJ, Men JM, Bouter LM. Pain 1995;63:279-88.

5. Browning R, Jackson JL, O’Malley PG. Arch Intern Med 2001;161:1613-20.

6. Faas A. Spine 1996;21:2874-8.

7. Cherkin DC, Deyo RA, Battie M, et al. N Engl J Med 1998;339:1021-9.

8. Assendelft WJJ, Koes BW, van der Heijden GJMG, Bouter LM. J Manipulative Physiol Ther 1996;19:499-507.

9. Institute for Clinical Systems Improvement (ICSI). ICSI health care guidelines no. GMS01. Bloomington, Minn: November 1999.

10. Bigos S, Bowyer O, Braen G, et al. AHCPR publication 95-0642, 1994.

References

1. van Tulder MW, Scholten RJ, Koes BW, Deyo RA. Cochrane Database Syst Rev 2000;2.-

2. Hagen KB, Hilde G, Jamtvedt G, Winnem M. Cochrane Syst Rev 2000;2.-

3. Rozenberg S, Dubourg G, Khalifa P, Paolozzi L, Maheu E, Ravaud P. Rev Rheum Engl Ed 1999;66:79-85.

4. Koes BW, Scholten RJ, Men JM, Bouter LM. Pain 1995;63:279-88.

5. Browning R, Jackson JL, O’Malley PG. Arch Intern Med 2001;161:1613-20.

6. Faas A. Spine 1996;21:2874-8.

7. Cherkin DC, Deyo RA, Battie M, et al. N Engl J Med 1998;339:1021-9.

8. Assendelft WJJ, Koes BW, van der Heijden GJMG, Bouter LM. J Manipulative Physiol Ther 1996;19:499-507.

9. Institute for Clinical Systems Improvement (ICSI). ICSI health care guidelines no. GMS01. Bloomington, Minn: November 1999.

10. Bigos S, Bowyer O, Braen G, et al. AHCPR publication 95-0642, 1994.

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Are there adverse maternal and neonatal outcomes associated with induction of labor when there is no well-accepted indication?

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Are there adverse maternal and neonatal outcomes associated with induction of labor when there is no well-accepted indication?

BACKGROUND: Elective inductions without a clear medical or obstetric indication are increasingly common. There are multiple studies suggesting that elective induction increases the risk of cesarean and instrumental delivery. However, the data are inconsistent, and many of the studies were performed before the introduction of cervical ripening agents. Therefore, it is unclear whether elective inductions without a medical or obstetric indication increase the risk of adverse outcomes under current practice guidelines.

POPULATION STUDIED: A sample of 2886 low-risk obstetric patients who underwent induction of labor without a medical or obstetric indication were compared with 9648 women with spontaneous labor. Eligibility criteria included women with single fetuses in a vertex position who delivered in the hospital between 37 and 41 weeks’ gestation. Women were excluded if an indication for induction was present according to the 1996 American College of Obstetrics and Gynecology (ACOG) guidelines. Of note, women who underwent induction for suspected macrosomia or post-term pregnancy before 42 weeks were not excluded from the study. The 2 populations of women were similar in most characteristics; however, those in the induction group were more likely to have a gestational age of 41 weeks or more (30% vs 18%), to have an infant with a birth weight of 4000 g or more (21.7% vs 13.3%), and to have medical insurance.

STUDY DESIGN AND VALIDITY: A sample of births in Washington State from 1989 to 1993 was obtained using birth certificates and linked hospital discharge data. Procedure codes and International Classification of Diseases—ninth revision codes used during the birth hospitalization were analyzed to determine whether a medical or obstetric indication for induction of labor was present. A random sample of women who underwent induction was compared with a random sample of women with spontaneous onset of labor. The retrospective cohort model was an appropriate design for this study. However, birth certificates and discharge data are often not complete with reference to the full hospitalization record. Because the charts from the birth hospitalization were not reviewed, a misclassification bias may have occurred. In addition, there are often unmeasured characteristics that influence the decision to induce labor that are not recorded on birth certificates or discharge data.

OUTCOMES MEASURED: The primary outcomes measured were the risk of cesarean or instrumental delivery (forceps or vacuum extraction) associated with elective induction of labor compared with spontaneous onset of labor. Other outcomes measured were risk of birth injury, 5-minute APGAR score less than 7, presence of meconium, and meconium aspiration.

RESULTS: Among women meeting the study eligibility criteria, the proportion of births by induction nearly doubled during the study period (10.2% in 1989 to 19.7% in 1993). Nulliparous women who were induced were more likely to have a cesarean delivery than those women with spontaneous onset of labor (19.4% vs 9.9%; relative risk [RR, adjusted for birth weight]=1.77; 95% confidence interval [CI], 1.50-2.08; number needed to harm [NNH]=11). For multiparous women there was no difference in cesarean delivery rate (4% in each group). The risk of instrumental vaginal delivery was slightly increased for women with induced labor (18.6% vs 15.5%; RR=1.20; 95% CI, 1.09-1.36; NNH=32). There was also an increase in the incidence of shoulder dystocia in the induction group (3% vs 1.7%; RR=1.32; 95% CI, 1.02-1.69). Of the other outcomes, the only difference between the groups was a decreased risk of moderate to heavy meconium present at birth in the induction group (4.4% vs 5.7%; RR=0.78; 95% CI, 0.65-0.95). However, this was not associated with a decreased risk of meconium aspiration. As these differences could potentially be confounded by a post-term gestation of 41 weeks or more, the authors repeated a data analysis including only women who delivered between 37 and 41 weeks. All outcomes were unchanged.

RECOMMENDATIONS FOR CLINICAL PRACTICE

Although limited by its retrospective design, this study found that women undergoing elective induction without an indication per ACOG guidelines are at a slightly increased risk for instrumental delivery. In particular, nulliparous women undergoing elective induction without a clear medical or obstetric indication are at increased risk for a cesarean delivery. These data may be useful to women and clinicians during the decision-making process when considering an elective induction.

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Marc I. Harwood, MD
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
E-mail:[email protected]

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Marc I. Harwood, MD
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
E-mail:[email protected]

Author and Disclosure Information

Marc I. Harwood, MD
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
E-mail:[email protected]

BACKGROUND: Elective inductions without a clear medical or obstetric indication are increasingly common. There are multiple studies suggesting that elective induction increases the risk of cesarean and instrumental delivery. However, the data are inconsistent, and many of the studies were performed before the introduction of cervical ripening agents. Therefore, it is unclear whether elective inductions without a medical or obstetric indication increase the risk of adverse outcomes under current practice guidelines.

POPULATION STUDIED: A sample of 2886 low-risk obstetric patients who underwent induction of labor without a medical or obstetric indication were compared with 9648 women with spontaneous labor. Eligibility criteria included women with single fetuses in a vertex position who delivered in the hospital between 37 and 41 weeks’ gestation. Women were excluded if an indication for induction was present according to the 1996 American College of Obstetrics and Gynecology (ACOG) guidelines. Of note, women who underwent induction for suspected macrosomia or post-term pregnancy before 42 weeks were not excluded from the study. The 2 populations of women were similar in most characteristics; however, those in the induction group were more likely to have a gestational age of 41 weeks or more (30% vs 18%), to have an infant with a birth weight of 4000 g or more (21.7% vs 13.3%), and to have medical insurance.

STUDY DESIGN AND VALIDITY: A sample of births in Washington State from 1989 to 1993 was obtained using birth certificates and linked hospital discharge data. Procedure codes and International Classification of Diseases—ninth revision codes used during the birth hospitalization were analyzed to determine whether a medical or obstetric indication for induction of labor was present. A random sample of women who underwent induction was compared with a random sample of women with spontaneous onset of labor. The retrospective cohort model was an appropriate design for this study. However, birth certificates and discharge data are often not complete with reference to the full hospitalization record. Because the charts from the birth hospitalization were not reviewed, a misclassification bias may have occurred. In addition, there are often unmeasured characteristics that influence the decision to induce labor that are not recorded on birth certificates or discharge data.

OUTCOMES MEASURED: The primary outcomes measured were the risk of cesarean or instrumental delivery (forceps or vacuum extraction) associated with elective induction of labor compared with spontaneous onset of labor. Other outcomes measured were risk of birth injury, 5-minute APGAR score less than 7, presence of meconium, and meconium aspiration.

RESULTS: Among women meeting the study eligibility criteria, the proportion of births by induction nearly doubled during the study period (10.2% in 1989 to 19.7% in 1993). Nulliparous women who were induced were more likely to have a cesarean delivery than those women with spontaneous onset of labor (19.4% vs 9.9%; relative risk [RR, adjusted for birth weight]=1.77; 95% confidence interval [CI], 1.50-2.08; number needed to harm [NNH]=11). For multiparous women there was no difference in cesarean delivery rate (4% in each group). The risk of instrumental vaginal delivery was slightly increased for women with induced labor (18.6% vs 15.5%; RR=1.20; 95% CI, 1.09-1.36; NNH=32). There was also an increase in the incidence of shoulder dystocia in the induction group (3% vs 1.7%; RR=1.32; 95% CI, 1.02-1.69). Of the other outcomes, the only difference between the groups was a decreased risk of moderate to heavy meconium present at birth in the induction group (4.4% vs 5.7%; RR=0.78; 95% CI, 0.65-0.95). However, this was not associated with a decreased risk of meconium aspiration. As these differences could potentially be confounded by a post-term gestation of 41 weeks or more, the authors repeated a data analysis including only women who delivered between 37 and 41 weeks. All outcomes were unchanged.

RECOMMENDATIONS FOR CLINICAL PRACTICE

Although limited by its retrospective design, this study found that women undergoing elective induction without an indication per ACOG guidelines are at a slightly increased risk for instrumental delivery. In particular, nulliparous women undergoing elective induction without a clear medical or obstetric indication are at increased risk for a cesarean delivery. These data may be useful to women and clinicians during the decision-making process when considering an elective induction.

BACKGROUND: Elective inductions without a clear medical or obstetric indication are increasingly common. There are multiple studies suggesting that elective induction increases the risk of cesarean and instrumental delivery. However, the data are inconsistent, and many of the studies were performed before the introduction of cervical ripening agents. Therefore, it is unclear whether elective inductions without a medical or obstetric indication increase the risk of adverse outcomes under current practice guidelines.

POPULATION STUDIED: A sample of 2886 low-risk obstetric patients who underwent induction of labor without a medical or obstetric indication were compared with 9648 women with spontaneous labor. Eligibility criteria included women with single fetuses in a vertex position who delivered in the hospital between 37 and 41 weeks’ gestation. Women were excluded if an indication for induction was present according to the 1996 American College of Obstetrics and Gynecology (ACOG) guidelines. Of note, women who underwent induction for suspected macrosomia or post-term pregnancy before 42 weeks were not excluded from the study. The 2 populations of women were similar in most characteristics; however, those in the induction group were more likely to have a gestational age of 41 weeks or more (30% vs 18%), to have an infant with a birth weight of 4000 g or more (21.7% vs 13.3%), and to have medical insurance.

STUDY DESIGN AND VALIDITY: A sample of births in Washington State from 1989 to 1993 was obtained using birth certificates and linked hospital discharge data. Procedure codes and International Classification of Diseases—ninth revision codes used during the birth hospitalization were analyzed to determine whether a medical or obstetric indication for induction of labor was present. A random sample of women who underwent induction was compared with a random sample of women with spontaneous onset of labor. The retrospective cohort model was an appropriate design for this study. However, birth certificates and discharge data are often not complete with reference to the full hospitalization record. Because the charts from the birth hospitalization were not reviewed, a misclassification bias may have occurred. In addition, there are often unmeasured characteristics that influence the decision to induce labor that are not recorded on birth certificates or discharge data.

OUTCOMES MEASURED: The primary outcomes measured were the risk of cesarean or instrumental delivery (forceps or vacuum extraction) associated with elective induction of labor compared with spontaneous onset of labor. Other outcomes measured were risk of birth injury, 5-minute APGAR score less than 7, presence of meconium, and meconium aspiration.

RESULTS: Among women meeting the study eligibility criteria, the proportion of births by induction nearly doubled during the study period (10.2% in 1989 to 19.7% in 1993). Nulliparous women who were induced were more likely to have a cesarean delivery than those women with spontaneous onset of labor (19.4% vs 9.9%; relative risk [RR, adjusted for birth weight]=1.77; 95% confidence interval [CI], 1.50-2.08; number needed to harm [NNH]=11). For multiparous women there was no difference in cesarean delivery rate (4% in each group). The risk of instrumental vaginal delivery was slightly increased for women with induced labor (18.6% vs 15.5%; RR=1.20; 95% CI, 1.09-1.36; NNH=32). There was also an increase in the incidence of shoulder dystocia in the induction group (3% vs 1.7%; RR=1.32; 95% CI, 1.02-1.69). Of the other outcomes, the only difference between the groups was a decreased risk of moderate to heavy meconium present at birth in the induction group (4.4% vs 5.7%; RR=0.78; 95% CI, 0.65-0.95). However, this was not associated with a decreased risk of meconium aspiration. As these differences could potentially be confounded by a post-term gestation of 41 weeks or more, the authors repeated a data analysis including only women who delivered between 37 and 41 weeks. All outcomes were unchanged.

RECOMMENDATIONS FOR CLINICAL PRACTICE

Although limited by its retrospective design, this study found that women undergoing elective induction without an indication per ACOG guidelines are at a slightly increased risk for instrumental delivery. In particular, nulliparous women undergoing elective induction without a clear medical or obstetric indication are at increased risk for a cesarean delivery. These data may be useful to women and clinicians during the decision-making process when considering an elective induction.

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