Status:
COMPLETED
Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Obese
Primiparous Women
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 progr...
Detailed Description
The hypothesis underlying this trial is that an increase in oxytocin dose can reduce the rate of caesarean sections in primiparous obese patients, with a spontaneous or induced onset of labour, withou...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT04760496
Start Date
October 2 2021
End Date
January 30 2025
Last Update
December 26 2025
Active Locations (12)
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1
CHU d'Angers
Angers, France
2
CHU de Bordeaux (Pellegrin)
Bordeaux, France
3
Hôpital Béclère
Clamart, France
4
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270