Alternative to Intensive Management of the Active Phase of the Second Stage of Labor (PASST)

Alternative to Intensive Management of the Active Phase of the Second Stage of Labor : a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Active Second Stage
• Intervention / Treatment: Procedure: "Moderate" management; Procedure: "Intensive" management

Detailed Description

Management of the active phase of the second stage of labor is not an evidence-based practice. Management of this phase differs between countries. 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.

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

The hypothesis is that "moderate" management of the active phase of the second stage allows decreasing frequency of neonatal morbidity at birth, decreasing frequency of operative delivery and increasing maternal satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 1701
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • paris
    • Paris, paris, France, 75014
      • Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria :

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

Exclusion Criteria :

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Moderate" management; 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; 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.
Active Comparator: "Intensive" management; Usual obstetrical care in France	Procedure: "Intensive" management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mode of delivery	spontaneous vaginal, instrumental vaginal delivery or cesarean section	at childbirth
Immediate postpartum complications	Perineal lesions with involvement of the anal sphincter (3rd and 4th degree)	2 hours after delivery
Immediate postpartum complications	Episiotomy	2 hours after delivery
Immediate postpartum complications	Cervical and vaginal lesion	2 hours after delivery
Immediate postpartum complications	Severe postpartum hemorrhage (blood loss estimated> 1000 mL, using sulprostone, intrauterine bloating, transfusion, uterine artery embolization, vessel ligation, uterine upholstery, of hysterectomy)	2 hours after delivery
Immediate postpartum complications	Postpartum Hemorrhage (blood loss estimated> 500mLand < 1000mL)	2 hours after delivery
Women satisfaction assessed with the Labour Agentry scale		2 hours after delivery
Women satisfaction assessed with the ICIQ-UI Short Form		6 months post partum
Urinary and anal incontinence assessed with the Wexner Score		6 months post partum

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Unité de Recherche Clinique Necker Cochin, France
• Investigators: Study Director: Pierre-Yves ANCEL, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Actual): March 25, 2021
• Study Completion (Actual): December 7, 2021

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimated): January 12, 2017

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Labor; Operative delivery; Neonatal morbidity; Active second stage
• Other Study ID Numbers: P150937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No