Effect of Immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery among Nulliparous Women Receiving Neuraxial Analgesia: A Randomized Clinical Trial

Alison G. Cahill, Sindhu K. Srinivas, Alan T.N. Tita, Aaron Caughey, Holly E. Richter, William (Tom) Gregory, Jingxia Liu, Candice Woolfolk, David L. Weinstein, Amit M. Mathur, George A. Macones, Methodius G. Tuuli

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Importance: It is unclear whether the timing of second stage pushing efforts affects spontaneous vaginal delivery rates and reduces morbidities. Objective: To evaluate whether immediate or delayed pushing results in higher rates of spontaneous vaginal delivery and lower rates of maternal and neonatal morbidities. Design, Setting, and Participants: Pragmatic randomized clinical trial of nulliparous women at or beyond 37 weeks' gestation admitted for spontaneous or induced labor with neuraxial analgesia between May 2014 and December 2017 at 6 US medical centers. The interim analysis suggested futility for the primary outcome and recruitment was terminated with 2414 of 3184 planned participants. Follow-up ended January 4, 2018. Interventions: Randomization occurred when participants reached complete cervical dilation. Immediate group participants (n = 1200) began pushing immediately. Delayed group participants (n = 1204) were instructed to wait 60 minutes. Main Outcomes and Measures: The primary outcome was spontaneous vaginal delivery. Secondary outcomes included total duration of the second stage, duration of active pushing, operative vaginal delivery, cesarean delivery, postpartum hemorrhage, chorioamnionitis, endometritis, perineal lacerations (≥second degree), and a composite outcome of neonatal morbidity that included neonatal death and 9 other adverse outcomes. Results: Among 2414 women randomized (mean age, 26.5 years), 2404 (99.6%) completed the trial. The rate of spontaneous vaginal delivery was 85.9% in the immediate group vs 86.5% in the delayed group, and was not significantly different (absolute difference, -0.6% [95% CI, -3.4% to 2.1%]; relative risk, 0.99 [95% CI, 0.96 to 1.03]). There was no significant difference in 5 of the 9 prespecified secondary outcomes reported, including the composite outcome of neonatal morbidity (7.3% for the immediate group vs 8.9% for the delayed group; between-group difference, -1.6% [95% CI, -3.8% to 0.5%]) and perineal lacerations (45.9% vs 46.4%, respectively; between-group difference, -0.4% [95% CI, -4.4% to 3.6%]). The immediate group had significantly shorter mean duration of the second stage compared with the delayed group (102.4 vs 134.2 minutes, respectively; mean difference, -31.8 minutes [95% CI, -36.7 to -26.9], P <.001), despite a significantly longer mean duration of active pushing (83.7 vs 74.5 minutes; mean difference, 9.2 minutes [95% CI, 5.8 to 12.6], P <.001), lower rates of chorioamnionitis (6.7% vs 9.1%; between-group difference, -2.5% [95% CI, -4.6% to -0.3%], P =.005), and fewer postpartum hemorrhages (2.3% vs 4.0%; between-group difference, -1.7% [95% CI, -3.1% to -0.4%], P =.03). Conclusions and Relevance: Among nulliparous women receiving neuraxial anesthesia, the timing of second stage pushing efforts did not affect the rate of spontaneous vaginal delivery. These findings may help inform decisions about the preferred timing of second stage pushing efforts, when considered with other maternal and neonatal outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02137200.

Original languageEnglish (US)
Pages (from-to)1444-1454
Number of pages11
JournalJAMA - Journal of the American Medical Association
Volume320
Issue number14
DOIs
StatePublished - Oct 9 2018

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Analgesia
Randomized Controlled Trials
Morbidity
Chorioamnionitis
Postpartum Hemorrhage
Lacerations
Pragmatic Clinical Trials
Mothers
Induced Labor
Medical Futility
Endometritis
Random Allocation
Dilatation
Anesthesia
Outcome Assessment (Health Care)
Pregnancy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effect of Immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery among Nulliparous Women Receiving Neuraxial Analgesia : A Randomized Clinical Trial. / Cahill, Alison G.; Srinivas, Sindhu K.; Tita, Alan T.N.; Caughey, Aaron; Richter, Holly E.; Gregory, William (Tom); Liu, Jingxia; Woolfolk, Candice; Weinstein, David L.; Mathur, Amit M.; Macones, George A.; Tuuli, Methodius G.

In: JAMA - Journal of the American Medical Association, Vol. 320, No. 14, 09.10.2018, p. 1444-1454.

Research output: Contribution to journalArticle

Cahill, Alison G. ; Srinivas, Sindhu K. ; Tita, Alan T.N. ; Caughey, Aaron ; Richter, Holly E. ; Gregory, William (Tom) ; Liu, Jingxia ; Woolfolk, Candice ; Weinstein, David L. ; Mathur, Amit M. ; Macones, George A. ; Tuuli, Methodius G. / Effect of Immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery among Nulliparous Women Receiving Neuraxial Analgesia : A Randomized Clinical Trial. In: JAMA - Journal of the American Medical Association. 2018 ; Vol. 320, No. 14. pp. 1444-1454.
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abstract = "Importance: It is unclear whether the timing of second stage pushing efforts affects spontaneous vaginal delivery rates and reduces morbidities. Objective: To evaluate whether immediate or delayed pushing results in higher rates of spontaneous vaginal delivery and lower rates of maternal and neonatal morbidities. Design, Setting, and Participants: Pragmatic randomized clinical trial of nulliparous women at or beyond 37 weeks' gestation admitted for spontaneous or induced labor with neuraxial analgesia between May 2014 and December 2017 at 6 US medical centers. The interim analysis suggested futility for the primary outcome and recruitment was terminated with 2414 of 3184 planned participants. Follow-up ended January 4, 2018. Interventions: Randomization occurred when participants reached complete cervical dilation. Immediate group participants (n = 1200) began pushing immediately. Delayed group participants (n = 1204) were instructed to wait 60 minutes. Main Outcomes and Measures: The primary outcome was spontaneous vaginal delivery. Secondary outcomes included total duration of the second stage, duration of active pushing, operative vaginal delivery, cesarean delivery, postpartum hemorrhage, chorioamnionitis, endometritis, perineal lacerations (≥second degree), and a composite outcome of neonatal morbidity that included neonatal death and 9 other adverse outcomes. Results: Among 2414 women randomized (mean age, 26.5 years), 2404 (99.6{\%}) completed the trial. The rate of spontaneous vaginal delivery was 85.9{\%} in the immediate group vs 86.5{\%} in the delayed group, and was not significantly different (absolute difference, -0.6{\%} [95{\%} CI, -3.4{\%} to 2.1{\%}]; relative risk, 0.99 [95{\%} CI, 0.96 to 1.03]). There was no significant difference in 5 of the 9 prespecified secondary outcomes reported, including the composite outcome of neonatal morbidity (7.3{\%} for the immediate group vs 8.9{\%} for the delayed group; between-group difference, -1.6{\%} [95{\%} CI, -3.8{\%} to 0.5{\%}]) and perineal lacerations (45.9{\%} vs 46.4{\%}, respectively; between-group difference, -0.4{\%} [95{\%} CI, -4.4{\%} to 3.6{\%}]). The immediate group had significantly shorter mean duration of the second stage compared with the delayed group (102.4 vs 134.2 minutes, respectively; mean difference, -31.8 minutes [95{\%} CI, -36.7 to -26.9], P <.001), despite a significantly longer mean duration of active pushing (83.7 vs 74.5 minutes; mean difference, 9.2 minutes [95{\%} CI, 5.8 to 12.6], P <.001), lower rates of chorioamnionitis (6.7{\%} vs 9.1{\%}; between-group difference, -2.5{\%} [95{\%} CI, -4.6{\%} to -0.3{\%}], P =.005), and fewer postpartum hemorrhages (2.3{\%} vs 4.0{\%}; between-group difference, -1.7{\%} [95{\%} CI, -3.1{\%} to -0.4{\%}], P =.03). Conclusions and Relevance: Among nulliparous women receiving neuraxial anesthesia, the timing of second stage pushing efforts did not affect the rate of spontaneous vaginal delivery. These findings may help inform decisions about the preferred timing of second stage pushing efforts, when considered with other maternal and neonatal outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02137200.",
author = "Cahill, {Alison G.} and Srinivas, {Sindhu K.} and Tita, {Alan T.N.} and Aaron Caughey and Richter, {Holly E.} and Gregory, {William (Tom)} and Jingxia Liu and Candice Woolfolk and Weinstein, {David L.} and Mathur, {Amit M.} and Macones, {George A.} and Tuuli, {Methodius G.}",
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language = "English (US)",
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TY - JOUR

T1 - Effect of Immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery among Nulliparous Women Receiving Neuraxial Analgesia

T2 - A Randomized Clinical Trial

AU - Cahill, Alison G.

AU - Srinivas, Sindhu K.

AU - Tita, Alan T.N.

AU - Caughey, Aaron

AU - Richter, Holly E.

AU - Gregory, William (Tom)

AU - Liu, Jingxia

AU - Woolfolk, Candice

AU - Weinstein, David L.

AU - Mathur, Amit M.

AU - Macones, George A.

AU - Tuuli, Methodius G.

PY - 2018/10/9

Y1 - 2018/10/9

N2 - Importance: It is unclear whether the timing of second stage pushing efforts affects spontaneous vaginal delivery rates and reduces morbidities. Objective: To evaluate whether immediate or delayed pushing results in higher rates of spontaneous vaginal delivery and lower rates of maternal and neonatal morbidities. Design, Setting, and Participants: Pragmatic randomized clinical trial of nulliparous women at or beyond 37 weeks' gestation admitted for spontaneous or induced labor with neuraxial analgesia between May 2014 and December 2017 at 6 US medical centers. The interim analysis suggested futility for the primary outcome and recruitment was terminated with 2414 of 3184 planned participants. Follow-up ended January 4, 2018. Interventions: Randomization occurred when participants reached complete cervical dilation. Immediate group participants (n = 1200) began pushing immediately. Delayed group participants (n = 1204) were instructed to wait 60 minutes. Main Outcomes and Measures: The primary outcome was spontaneous vaginal delivery. Secondary outcomes included total duration of the second stage, duration of active pushing, operative vaginal delivery, cesarean delivery, postpartum hemorrhage, chorioamnionitis, endometritis, perineal lacerations (≥second degree), and a composite outcome of neonatal morbidity that included neonatal death and 9 other adverse outcomes. Results: Among 2414 women randomized (mean age, 26.5 years), 2404 (99.6%) completed the trial. The rate of spontaneous vaginal delivery was 85.9% in the immediate group vs 86.5% in the delayed group, and was not significantly different (absolute difference, -0.6% [95% CI, -3.4% to 2.1%]; relative risk, 0.99 [95% CI, 0.96 to 1.03]). There was no significant difference in 5 of the 9 prespecified secondary outcomes reported, including the composite outcome of neonatal morbidity (7.3% for the immediate group vs 8.9% for the delayed group; between-group difference, -1.6% [95% CI, -3.8% to 0.5%]) and perineal lacerations (45.9% vs 46.4%, respectively; between-group difference, -0.4% [95% CI, -4.4% to 3.6%]). The immediate group had significantly shorter mean duration of the second stage compared with the delayed group (102.4 vs 134.2 minutes, respectively; mean difference, -31.8 minutes [95% CI, -36.7 to -26.9], P <.001), despite a significantly longer mean duration of active pushing (83.7 vs 74.5 minutes; mean difference, 9.2 minutes [95% CI, 5.8 to 12.6], P <.001), lower rates of chorioamnionitis (6.7% vs 9.1%; between-group difference, -2.5% [95% CI, -4.6% to -0.3%], P =.005), and fewer postpartum hemorrhages (2.3% vs 4.0%; between-group difference, -1.7% [95% CI, -3.1% to -0.4%], P =.03). Conclusions and Relevance: Among nulliparous women receiving neuraxial anesthesia, the timing of second stage pushing efforts did not affect the rate of spontaneous vaginal delivery. These findings may help inform decisions about the preferred timing of second stage pushing efforts, when considered with other maternal and neonatal outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02137200.

AB - Importance: It is unclear whether the timing of second stage pushing efforts affects spontaneous vaginal delivery rates and reduces morbidities. Objective: To evaluate whether immediate or delayed pushing results in higher rates of spontaneous vaginal delivery and lower rates of maternal and neonatal morbidities. Design, Setting, and Participants: Pragmatic randomized clinical trial of nulliparous women at or beyond 37 weeks' gestation admitted for spontaneous or induced labor with neuraxial analgesia between May 2014 and December 2017 at 6 US medical centers. The interim analysis suggested futility for the primary outcome and recruitment was terminated with 2414 of 3184 planned participants. Follow-up ended January 4, 2018. Interventions: Randomization occurred when participants reached complete cervical dilation. Immediate group participants (n = 1200) began pushing immediately. Delayed group participants (n = 1204) were instructed to wait 60 minutes. Main Outcomes and Measures: The primary outcome was spontaneous vaginal delivery. Secondary outcomes included total duration of the second stage, duration of active pushing, operative vaginal delivery, cesarean delivery, postpartum hemorrhage, chorioamnionitis, endometritis, perineal lacerations (≥second degree), and a composite outcome of neonatal morbidity that included neonatal death and 9 other adverse outcomes. Results: Among 2414 women randomized (mean age, 26.5 years), 2404 (99.6%) completed the trial. The rate of spontaneous vaginal delivery was 85.9% in the immediate group vs 86.5% in the delayed group, and was not significantly different (absolute difference, -0.6% [95% CI, -3.4% to 2.1%]; relative risk, 0.99 [95% CI, 0.96 to 1.03]). There was no significant difference in 5 of the 9 prespecified secondary outcomes reported, including the composite outcome of neonatal morbidity (7.3% for the immediate group vs 8.9% for the delayed group; between-group difference, -1.6% [95% CI, -3.8% to 0.5%]) and perineal lacerations (45.9% vs 46.4%, respectively; between-group difference, -0.4% [95% CI, -4.4% to 3.6%]). The immediate group had significantly shorter mean duration of the second stage compared with the delayed group (102.4 vs 134.2 minutes, respectively; mean difference, -31.8 minutes [95% CI, -36.7 to -26.9], P <.001), despite a significantly longer mean duration of active pushing (83.7 vs 74.5 minutes; mean difference, 9.2 minutes [95% CI, 5.8 to 12.6], P <.001), lower rates of chorioamnionitis (6.7% vs 9.1%; between-group difference, -2.5% [95% CI, -4.6% to -0.3%], P =.005), and fewer postpartum hemorrhages (2.3% vs 4.0%; between-group difference, -1.7% [95% CI, -3.1% to -0.4%], P =.03). Conclusions and Relevance: Among nulliparous women receiving neuraxial anesthesia, the timing of second stage pushing efforts did not affect the rate of spontaneous vaginal delivery. These findings may help inform decisions about the preferred timing of second stage pushing efforts, when considered with other maternal and neonatal outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02137200.

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