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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1701 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2021-12-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Active Second Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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"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.

Group Type EXPERIMENTAL

"Moderate" management

Intervention Type PROCEDURE

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.

"Intensive" management

Usual obstetrical care in France

Group Type ACTIVE_COMPARATOR

"Intensive" management

Intervention Type PROCEDURE

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.

Interventions

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"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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No