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Alternative to Intensive Management of the Active Phase of the Second Stage of Labor

NCT03018860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1701

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

  • Active Second Stage

Interventions

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.

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.

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Pierre-Yves ANCEL, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-25
Primary Completion
2021-03-25
Completion
2021-12-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03018860 on ClinicalTrials.gov