4 - Reducing neonatal morbidity by discontinuing oxytocin during the active phase: The STOPOXY Trial

Thursday, February 9, 2023

8:45 AM – 9:00 AM

Location: Moscone West, Level 3

Objective: Oxytocin is effective in reducing labor duration but can be associated with fetal and maternal complications. Previous studies evaluating discontinuous oxytocin were underpowered to show a reduction in neonatal morbidity. We aimed at evaluating the impact of discontinuing oxytocin during the active phase on neonatal morbidity.

Study Design: STOPOXY was a multicenter, randomized, open-label trial including women with a live term cephalic singleton, receiving oxytocin before 4cm. Women < 18 years with a scarred uterus, multiple pregnancy, fetal malformation, IUGR or abnormal FHR were excluded. Women were randomized < 6cm when oxytocin was continued or discontinued. The primary outcome, neonatal morbidity was assessed using a composite variable defined by an umbilical arterial pH < 7.10 and/or base excess > 10 mmol/L and/or umbilical arterial lactates > 7 mmol/L and/or 5min Apgar score < 7 and/or admission in NICU. Secondary outcomes included neonatal complications, duration of active first stage, delivery mode and maternal complications.The two groups were compared using an intention to treat analysis.

Results: We randomized 2367 women, 1175 in the intervention group (discontinuous oxytocin) and 1192 in the control group (continuous oxytocin). The population was composed of 55.8% primiparous with a median age of 32 years, and BMI of 24.1 kg/m2. The neonatal morbidity rate was 12.4% in the intervention group and 12.4% in the control group (p=0.96). Cesarean delivery rates and PPH rates were comparable between the two groups (18.8% vs 16.5%, p=0.22 and 12.9% vs 12.6%, p=0.84). Apart from active first stage duration which was significantly higher in the intervention group (100min, IQR[50;208] vs 90min, [45;150], p=0.001), there were no significant differences between the groups.

Conclusion: Discontinuing oxytocin during the active phase of labor did not improve neonatal morbidity or increase other neonatal or maternal outcomes.

Primary & Presenting Author(s)

Aude Girault, MD, PhD (she/her/hers)

Université de Paris Cité, INSERM UMR 1153, Equipe EPOPé,
Paris, Ile-de-France, France

Slides

Coauthor(s)

Loïc Sentilhes, MD, PhD (he/him/his)

Head of Department of Obstetrics and Gynecology
Department of Obstetrics and Gynecology, Bordeaux Universitary Hospital
Aquitaine, Aquitaine, France
RD

Raoul Desbriere, MD

St Joseph Hospital Marseille
Provence-Alpes-Cote d'Azur, France, France
PR

Patrick Rozenberg, MD

Centrre Hospitalier Poissy Saint-Germain
Poissy, Paraguay, Paraguay
Diane Korb, MD, PhD

Université de Paris, Centre for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOPé, INSERM, INRA
Paris, France, France
CB

Charline Bertholdt, MD, PhD

Department of Obstetrics and Gynecology, Nancy University Hospital
Nancy, Lorraine, France
JC

Julie Carrara, MD

Department of Obstetrics and Gynecology, Antoine Béclère Hospital, Assistance Publique-Hôpitaux de Paris
Clamart, Ile-de-France, France
NW

Norbert Winer, MD, PhD

Department of Obstetrics and Gynecology, Nantes University Hospital, NUN, INRAE, UMR 1280, PhAN, University of Nantes, Nantes, France
Nantes, Pays de la Loire, France
EV

Eric Verspyck, MD, PhD

Rouen Univesity Hospital
Haute-Normandie, France, France
EB

Eric Boudier, MD

Department of Obstetrics and Gynecology, Strasbourg University Hospital
Strasbourg, Alsace, France
TB

Tiphaine Barjat, MD

Department of Obstetrics and Gynecology, Saint-Etienne University Hospital, Saint-Etienne,
Saint-Priest-en-Jarez, Rhone-Alpes, France
GL

Gilles Levy, MD

Department of Obstetrics and Gynecology, Belfort Hospital,
Trevenans, Franche-Comte, France
GR

Georges Emmanuel Roth, MD

Department of Obstetrics and Gynecology, Strasbourg University Hospital
Strasbourg, Alsace, France
GK

Gilles Kayem, MD, PhD

Armand-Trousseau Hospital
Paris, France, France
MM

Mona Massoud, MD, PhD

Department of Obstetrics and Gynecology, Hospital Femme-Mère-Enfant, Hospices Civils de Lyon, University Lyon 1,
Lyon, Rhone-Alpes, France
CB

Caroline Bohec, MD

Department of Obstetrics and Gynecology, Pau Hospital
Pau, Aquitaine, France
PG

Paul Guerby, MD, PhD

Department of Obstetrics and Gynecology, Toulouse University Hospital
Toulouse, Midi-Pyrenees, France
EA

Elie Azria, MD, PhD

INSERM UMR 1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team (Epopé), Centre for Epidemiology and Statistics Sorbonne Paris Cité, Paris Descartes University
Paris, Ile-de-France, France
Julie Blanc, MD, PhD

Obstetrician and Gynecologist
Department of Obstetrics and Gynecology, Nord Hospital, Assistance Publique - Hopitaux de Marseille (AP-HM), Aix Marseille University (AMU), Marseille, France.
APHM / AMU, Provence-Alpes-Cote d'Azur, France
HH

Helene Heckenroth, MD

Department of Obstetrics and Gynecology, Conception Hospital, Assistance Publique-Hôpitaux de Marseille,
Marseille, Provence-Alpes-Cote d'Azur, France
Charles Garabedian, MD, PhD

CHU Lille
Lille, Nord-Pas-de-Calais, France
Camille Le Ray, MD, PhD

APHP, Port Royal Maternity Unit
Paris, France, France