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

Not Applicable

Completed

• Conditions: Active Second Stage
• Interventions: Procedure: "Intensive" management; Procedure: "Moderate" management

• Registration Number: NCT03018860
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Study Start: 2017-01-25
• Primary Completion: 2021-03-25
• Status Verified: 2021-06
• Study Completion: 2021-12-07
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1701

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Intensive" management	"Intensive" management	Usual obstetrical care in France
"Moderate" management	"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.

Primary Outcome Measures

Name	Time	Method
Neonatal morbidity composite measure	at childbirth	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)

Secondary Outcome Measures

Name	Time	Method
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
Mode of delivery	at childbirth	spontaneous vaginal, instrumental vaginal delivery or cesarean section
Women satisfaction assessed with the Labour Agentry scale	2 hours after delivery
Immediate postpartum complications	2 hours after delivery	Postpartum Hemorrhage (blood loss estimated\> 500mLand \< 1000mL)

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, France