Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous Labour.

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: Female

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 progress of labour, but observational studies have suggested that its efficiency may be insufficient in obese women with usual doses.

The research is 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 labour between two oxytocin dosage regimens.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Oxytocin

Criteria

Inclusion criteria

Inclusion criteria are the following:

• Age ≥ 18 years

• Nulliparous

• BMI ≥ 30 kg/m² at the beginning of pregnancy

• Singleton pregnancy

• Spontaneous 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 malformations

• Foetal heart rate anomalies before the use of oxytocin

• History of uterine surgery

• Patient with a disease requiring induction of labour or caesarean section prior to labour

• Severe renal failure

• Patient deprived of their liberty (under curator or guardianship)

• Participation in another interventional trial