NCT04760496CompletedPhase 4
Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour
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
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
The rate of caesarean section is higher among obese pregnant women, leading to increased morbidity in this already vulnerable population. Oxytocin is the main drug used in obstetrics to optimize progress of labour, but observational studies have suggested that its efficiency may be insufficient in obese women with usual doses. We design a randomised controlled trial to test the effect of an increased oxytocin dose on the rate of caesarean section in obese primiparous women with spontaneous or induced labour.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 443 (actual)
- First submitted
- 29 Jan 2021
- Start date
- 2 Oct 2021
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Obesity
- NCT number
- NCT04760496
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 443
- From 2 Oct 2021 to the primary completion date, 30 Dec 2024
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with a disease requiring caesarean section prior to labour (planned caesarean section before labour)
Other illness
- Hypersensitivity to the active substance (oxytocin), to any of its excipients or to latex (risk of cross allergy)
- Coagulation disorders
- Foetal heart rate anomalies before use of oxytocin (at the time of inclusion)
- History of uterine surgery (scarred uterus of gynaecological origin)
- Severe renal failure
Other
- Medical contraindication for oxytocin
- Foetal growth restriction (inferior to 5th percentile)
- Foetal malformation (major)
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHU de Bordeaux - Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Hôpital Béclère Coordinator of this site? Confirm its status | Clamart | France | Unknown status |
| Hopital Bicetre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Hôpital Tenon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Cochin - Port Royal Coordinator of this site? Confirm its status | PARIS | France | Unknown status |
| CHU de Poissy St Germain Coordinator of this site? Confirm its status | Poissy | France | Unknown status |
| Chu de Saint Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| CHU de Strasbourg (Centre Médico Chirurgical et Obstétrical) Coordinator of this site? Confirm its status | Schiltigheim | France | Unknown status |
| CHU de Strasbourg Hôpital de Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.