NCT03018860

Brief Summary

Active phase of the second stage of labor corresponds to period of maternal expulsive efforts (i.e. pushing). An intensive management of this phase is usual in France. This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,701

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

January 25, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

4.2 years

First QC Date

January 3, 2017

Last Update Submit

August 29, 2025

Conditions

Active Second Stage

Keywords

Active second stageNeonatal morbidityOperative deliveryLabor

Outcome Measures

Primary Outcomes (1)

  • Neonatal morbidity composite measure

    number of participant with acidosis arterial cord pH \<7.15 and / or excess base\> 10 mmol / L and / or lactate\> 6 mmol / L and or an Apgar score at 5 minutes \<7 and or severe neonatal trauma defined by fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure) and or an Apgar score at 5 minutes \<7 and or severe neonatal trauma: fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure)

    at childbirth

Secondary Outcomes (9)

  • Mode of delivery

    at childbirth

  • Immediate postpartum complications

    2 hours after delivery

  • Immediate postpartum complications

    2 hours after delivery

  • Immediate postpartum complications

    2 hours after delivery

  • Immediate postpartum complications

    2 hours after delivery

  • +4 more secondary outcomes

Study Arms (2)

"Moderate" management

EXPERIMENTAL

Women are encouraged by physicians to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.

Procedure: "Moderate" management

"Intensive" management

ACTIVE COMPARATOR

Usual obstetrical care in France

Procedure: "Intensive" management

Interventions

"Moderate" managementPROCEDURE

After randomization, women allocated to the intervention group, i.e. "moderate" pushing, are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.

"Moderate" management
"Intensive" managementPROCEDURE

This group corresponds to usual obstetrical management of active second stage in France. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.

"Intensive" management

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primiparous women
  • singleton fetus
  • fetal cephalic presentation
  • ≥37 gestational weeks
  • living fetus
  • Patient with epidural analgesia
  • Major Female
  • Women understand French

You may not qualify if:

  • Abnormal fetal heart rate requiring hastening childbirth
  • cervical dilatation \< 8 cm
  • intrauterine fetal growth restriction \<5e percentile,
  • Fetal malformation,
  • history of gynecological surgery with uterine scar
  • Women do not understand French,
  • women with psychiatric condition
  • contraindication to intensive management of active second stage (severe myopia, respiratory or cardiac failure)
  • no affiliation to a social security scheme (beneficiary or assignee)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, paris, 75014, France

Location

Related Publications (7)

  • Le Ray C, Rozenberg P, Kayem G, Harvey T, Sibiude J, Doret M, Parant O, Fuchs F, Vardon D, Azria E, Senat MV, Ceccaldi PF, Seco A, Garabedian C, Chantry AA; Groupe de Recherche en Obstetrique et Gynecologie. Alternative to intensive management of the active phase of the second stage of labor: a multicenter randomized trial (Phase Active du Second STade trial) among nulliparous women with an epidural. Am J Obstet Gynecol. 2022 Oct;227(4):639.e1-639.e15. doi: 10.1016/j.ajog.2022.07.025. Epub 2022 Jul 19.

    PMID: 35868416BACKGROUND

  • Le Ray C, Audibert F. [Duration of pushing in labor: literature review]. J Gynecol Obstet Biol Reprod (Paris). 2008 Jun;37(4):325-8. doi: 10.1016/j.jgyn.2008.02.009. Epub 2008 Apr 10. French.

    PMID: 18406074BACKGROUND

  • Nordstrom L, Achanna S, Naka K, Arulkumaran S. Fetal and maternal lactate increase during active second stage of labour. BJOG. 2001 Mar;108(3):263-8. doi: 10.1111/j.1471-0528.2001.00034.x.

    PMID: 11281466BACKGROUND

  • Le Ray C, Audibert F, Goffinet F, Fraser W. When to stop pushing: effects of duration of second-stage expulsion efforts on maternal and neonatal outcomes in nulliparous women with epidural analgesia. Am J Obstet Gynecol. 2009 Oct;201(4):361.e1-7. doi: 10.1016/j.ajog.2009.08.002.

    PMID: 19788968BACKGROUND

  • Cheng YW, Hopkins LM, Caughey AB. How long is too long: Does a prolonged second stage of labor in nulliparous women affect maternal and neonatal outcomes? Am J Obstet Gynecol. 2004 Sep;191(3):933-8. doi: 10.1016/j.ajog.2004.05.044.

    PMID: 15467567BACKGROUND

  • Dionne MD, Deneux-Tharaux C, Dupont C, Basso O, Rudigoz RC, Bouvier-Colle MH, Le Ray C. Duration of Expulsive Efforts and Risk of Postpartum Hemorrhage in Nulliparous Women: A Population-Based Study. PLoS One. 2015 Nov 10;10(11):e0142171. doi: 10.1371/journal.pone.0142171. eCollection 2015.

    PMID: 26555447BACKGROUND

  • Dupuis N, Pizzoferrato AC, Garabedian C, Rozenberg P, Kayem G, Harvey T, Mandelbrot L, Doret M, Fuchs F, Azria E, Senat MV, Ceccaldi PF, Seco A, Chantry A, Le Ray C; GROG (Groupe de Recherche en Obstetrique et Gynecologie). Moderate or intensive management of the active phase of second-stage labor and risk of urinary and anal incontinence: results of the PASST randomized controlled trial. Am J Obstet Gynecol. 2023 Nov;229(5):528.e1-528.e17. doi: 10.1016/j.ajog.2023.07.034. Epub 2023 Jul 26.

    PMID: 37499991DERIVED

Study Officials

  • Pierre-Yves ANCEL, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 12, 2017

Study Start

January 25, 2017

Primary Completion

March 25, 2021

Study Completion

December 7, 2021

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)