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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Active Second Stage

Treatments: Procedure: "Intensive" management; Procedure: "Moderate" management

Study type: Interventional

Funder types: Other

Identifiers

NCT03018860

P150937

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,701 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,701 participants in 2 patient groups

"Moderate" management

Experimental group

Description:

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.

Treatment:

Procedure: "Moderate" management

"Intensive" management

Active Comparator group

Description:

Usual obstetrical care in France

Treatment:

Procedure: "Intensive" management