drugset / Trial / NCT03991091
Reducing Neonatal Morbidity by Discontinuing Oxytocin During the Active Phase of 1st Stage of Labor
Phase 4
Completed
2459 enrolled
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France · collabURC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-01-17
- Primary completion
- 2022-04-25
- Completion
- 2022-04-25
Publications
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxytocin | Peptide | — | — |
Indications
No indication recorded.