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

Assistance Publique - Hôpitaux de Paris1,701 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

1,701

Conditions

Active Second Stage

Interventions

"Moderate" managementPROCEDURE

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" managementPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Cochin Hospital

Paris, Paris, France

Outcomes

Primary Outcomes

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)

Time frame: at childbirth