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

NCT03991091 | Completed Phase 4

• 1 other identifier: APHP180581
• Study Type: interventional
• Target: 2,459
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Morbidity

Keywords

Multicenter; randomized; control study; Oxytocin discontinuation; Neonatal acidosis

Outcome Measures

Primary Outcomes (1)

• neonatal morbidity composite measure

  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\[16\]

  At birth

Secondary Outcomes (23)

• umbilical cord pH<7.20

  At birth

• umbilical cord pH<7.10

  At birth

• umbilical cord pH<7.00

  At birth

• Need for hypothermia

  At birth

• other neonatal complications:

  2 hours postpartum

Study Arms (2)

discontinuation of oxytocin administration

EXPERIMENTAL

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

Drug: discontinuation of oxytocin administration

continuation of oxytocin administration

ACTIVE COMPARATOR

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.

Drug: continuation of oxytocin administration

Interventions

continuation of oxytocin administration DRUG

continuation of oxytocin administration

continuation of oxytocin administration

discontinuation of oxytocin administration DRUG

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. In the experimental group, oxytocin can be re-started, if necessary, after 2 hours of arrest of labor.

discontinuation of oxytocin administration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With a term (≥37 WG) pregnancy
• Singleton pregnancy
• Fetus in cephalic presentation
• Women receiving oxytocin during the latent phase of the 1st stage of labor, before 4 cm of cervical dilatation, including women with an induction of labor using cervical ripening or oxytocin
• Speaking and reading French language
• Affiliated to social security
• Who have signed the consent form

You may not qualify if:

• Women with a scarred uterus
• Fetus with a congenital anomaly
• Fetal growth retardation \<3rd percentile
• Having an abnormal fetal heart rate at randomization
• Maternal age \< 18 years
• Participating in another trial involving medication

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

hospital Cochin; port royal Maternity unit

Paris, 75014, France

Location

Related Publications (2)

• Girault A, Sentilhes L, Desbriere R, Berveiller P, Korb D, Bertholdt C, Carrara J, Winer N, Verspyck E, Boudier E, Barjat T, Levy G, Roth GE, Kayem G, Massoud M, Bohec C, Guerby P, Azria E, Blanc J, Heckenroth H, Rousseau J, Garabedian C, Le Ray C; collaborators of the STOPOXY trial and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). Impact of discontinuing oxytocin in active labour on neonatal morbidity: an open-label, multicentre, randomised trial. Lancet. 2023 Dec 2;402(10417):2091-2100. doi: 10.1016/S0140-6736(23)01803-2. Epub 2023 Nov 9.

  PMID: 37952548 RESULT

• Girault A, Goffinet F, Le Ray C; collaborators of the STOPOXY trial and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). Reducing neonatal morbidity by discontinuing oxytocin during the active phase of first stage of labor: a multicenter randomized controlled trial STOPOXY. BMC Pregnancy Childbirth. 2020 Oct 20;20(1):640. doi: 10.1186/s12884-020-03331-x.

  PMID: 33081758 RESULT

Study Officials

• Camille Le Ray, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 19, 2019
• Study Start: January 17, 2020
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)