Reducing Neonatal Morbidity by Discontinuing Oxytocin During the Active Phase of 1st Stage of Labor

Status

Completed

Phase

Phase 4

Enrollment

2,459 participants (actual)

Sponsor

Assistance Publique - Hôpitaux de Paris · Other

Design

Randomized · Open label (no masking)

Countries

1 country

France

Start

17 Jan 2020

Primary completion

25 Apr 2022

Completion

25 Apr 2022

First posted

19 Jun 2019

Last update posted

5 Feb 2026

Conditions

Neonatal Morbidity

The purpose of this study is to measure the impact of a discontinuous administration of oxytocin during the active phase of the 1st stage of labor on the neonatal morbidity rate. The investigators hypothesize that discontinuation of oxytocin in the active phase of labor (from 6 cm) in women who received oxytocin in the latent phase or for an induction (before 4 cm of dilation) could reduce neonatal morbidity.

• Experimental

  discontinuation of oxytocin administration

  Discontinuation of oxytocin administration at the beginning of the active phase of the 1st stage of labor, i.e. oxytocin infusion will be stopped beyond a cervical dilatation of 6cm

• Active comparator

  continuation of oxytocin administration

  Standard care in France, i.e. when oxytocin is started during the latent phase of the 1st stage, administration of oxytocin is continued during the active 1st stage and during the 2nd stage if the fetal heart rate is reassuring.

1. neonatal morbidity composite measure

   Time frame · At birth

   Registry description

   Neonatal morbidity will be assessed using a composite variable defined by: an umbilical arterial pH at birth \<7.10 and/or a base excess \>10mmol/L and/or umbilical arterial lactates\>7 mmol/L and/or a 5 minutes Apgar score \<7 and/or admission in neonatal intensive care unit (NICU). This composite outcome is based on pertinent and previously published thresholds to assess neonatal acidosis\[16\]