Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous Labour.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obese
- Oxytocin
- Primiparous Women
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: There is two group of patient for which the prescription of oxytocin is required for the care : the control group will receive will receive oxytocin at 2 mIU/mL (standard dose) the experimental group will receive oxytocin at 4 mIU/mLMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: An "out-of-protocol" healthcare professional (midwife / nurse) will prepare oxytocin. The "out-of-protocol" healthcare professional (midwife / nurse) will not be a study's investigator, and will not be involved in the patient's care. The randomization group will not be communicated to the investigator or any medical personnel involved in the study or patient by the "out-of-protocol" nurse/midwife, in order to preserve the double-blind design.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 onset of labour, without increasing maternal or neonatal morbidity. This would be a major step forward in reducing morbidity in an at-...
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 onset of labour, without increasing maternal or neonatal morbidity. This would be a major step forward in reducing morbidity in an at-risk population and in improving the obstetric prognosis for future pregnancies. The research is a double-blind controlled trial, including primiparous obese women in spontaneous labour, for whom a prescription of oxytocin is decided. Oxytocin is currently indicated for notably "insufficiency of uterine contractions, at the beginning or during labour".The recommended dosage in the market authorization will be used for the control group. The control group will receive oxytocin at 2 milli-International unit /mL and the intervention group at 4 milli-International unit /mL, controlled by pump (final volume = 500 mL) or electrical syringe (final volume = 50 mL). The primary objective is to compare the effect of higher doses of oxytocin (intervention group) vs standard doses of oxytocin (control group) on the rate of caesarean sections in obese patients with spontaneous onset of labour. The secondary objectives will be to compare the effect of higher doses of oxytocin (intervention group) vs standard doses of oxytocin (control group) on maternal and labour complications (length of labour, arrest of labour, interruption of oxytocin perfusion and reason, uterine hyper-stimulation, mode of vaginal delivery, reason for caesarean section, post-partum haemorrhage, maternal blood transfusion, volume of oxytocin infusion, oxytocin side effects), as well as foetal complications and neonatal complications.
Tracking Information
- NCT #
- NCT04760496
- Collaborators
- Not Provided
- Investigators
- Not Provided
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