Increasing oxytocin doses to reduce caesarean sections in obese first-time mothers during labor
Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour. A Double-blind, Randomised, Controlled Trial
This study is testing if giving higher doses of oxytocin during labor can help first-time obese mothers have fewer caesarean sections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 882 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 14 sites (Angers and 13 other locations) |
| Trial ID | NCT04760496 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether higher doses of oxytocin can decrease the rate of caesarean sections in obese primiparous women who are experiencing spontaneous or induced labor. It is a double-blind, randomized controlled trial comparing standard oxytocin doses with increased doses administered via pump or electrical syringe. The primary goal is to assess the impact of these doses on the incidence of caesarean deliveries, while secondary objectives include evaluating maternal and labor complications. The study aims to improve outcomes for a vulnerable population by optimizing labor management with oxytocin.
Who should consider this trial
Good fit: Ideal candidates are obese primiparous women aged 18 and older, with a BMI of 30 or higher, who are at term and experiencing spontaneous or induced labor.
Not a fit: Patients who may not benefit include those with medical contraindications for oxytocin, significant fetal anomalies, or prior uterine surgeries.
Why it matters
Potential benefit: If successful, this approach could significantly lower the rate of caesarean sections in obese first-time mothers, reducing associated morbidity.
How similar studies have performed: Previous observational studies suggest that increasing oxytocin doses may improve labor outcomes in similar populations, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria Inclusion criteria are the following: * Age ≥ 18 years * Nulliparous (no previous childbirth beyond 22 SA) * BMI ≥ 30 kg/m² at the beginning of pregnancy * Singleton pregnancy * Spontaneous or induced onset of labour * Cephalic presentation * Term ≥ 37 weeks of gestation and \< 42 weeks of gestation * Medical Indication and absence of medical contraindication for oxytocin during labour: inadequate and/or ineffective uterine contraction and/or delayed cervical dilation * Written consent * Affiliation to a french social security system Exclusion criteria Exclusion criteria are the following: * Hypersensitivity to the active substance (oxytocin), to any of its excipients or to latex (risk of cross allergy) * Medical contraindication for oxytocin * Coagulation disorders * Foetal growth restriction (inferior to 5th percentile) * Foetal malformation (major) * Foetal heart rate anomalies before use of oxytocin (at the time of inclusion) * History of uterine surgery (scarred uterus of gynaecological origin) * Patient with a disease requiring caesarean section prior to labour (planned caesarean section before labour) * Severe renal failure * Patient deprived of their liberty (under curatorship or guardianship) * Participation in another interventional trial of category 1. Patients included in interventional research with minimal risk and constraints may participate in the study after the investigator's assessment.
Where this trial is running
Angers and 13 other locations
- CHU d'Angers — Angers, France (Recruiting)
- Hôpital Jean Verdier — Bondy, France (Not_yet_recruiting)
- CHU de Bordeaux (Pellegrin) — Bordeaux, France (Recruiting)
- Hôpital Béclère — Clamart, France (Recruiting)
- Hôpital Bicêtre — Le Kremlin Bicêtre, France (Recruiting)
- CHRU Lille — Lille, France (Not_yet_recruiting)
- CHU de Montpellier — Montpellier, France (Recruiting)
- CHU de Nimes — Nîmes, France (Recruiting)
- Hôpital Cochin Port Royal — Paris, France (Recruiting)
- Hôpital Tenon — Paris, France (Recruiting)
- CHU de Poissy St Germain — Poissy, France (Recruiting)
- CHU de Saint Etienne — Saint-Étienne, France (Recruiting)
- CHU de Strasbourg (Centre Médico Chirurgical et Obstétrical) — Schiltigheim, France (Recruiting)
- CHU de Strasbourg (Hôpital de Hautepierre) — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Alexandra BENACHI, PHD, MD — Antoine Béclère Hospital, APHP
- Study coordinator: Alexandra BENACHI, PHD, MD
- Email: alexandra.benachi@aphp.fr
- Phone: +33145374476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.