To compare the rates of caesarean section in obese patients with spontaneous labour between two oxytocin dosage regimens
Conditions
Interventions
Trade Name: OXYTOCINE MEDISOL 5 UI/mL, solution injectable
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: OXYTOCIN
CAS Number: 50-56-6
Concentration unit: IU/ml internationa
Sponsors
ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years - Nulliparous - Singleton pregnancy - Obesity defined as BMI = 30 kg/m2 (during first trimester of pregnancy) - Spontaneous onset of labour - Cephalic presentation - Term = 37 weeks of gestation and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Hypersensitivity to the active substance (oxytocin) or to any of its excipients - Medical contraindication for oxytocin - Coagulation disorders - Foetal growth restriction (inferior to 5th percentile) - Foetal malformation - Foetal heart rate anomalies before use of oxytocin - History of uterine surgery - Patient with a disease requiring induction of labour or caesarean section prior to labour - Curatorship or guardianship - Participation in another interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: a. 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•Foetal complications •Neonatal complications b. To create a biobank of maternal and cord blood.This bank will be used for an ancillary study part of the SENEC project which has been recently created as a FHU. The SENEC project aims at developing a multidisciplinary approach common to chronic diseases (red blood-cell, neurodegenerative, lung, cardiovascular & metabolic including obesity) ;Primary end point(s): To compare the rates of caesarean section in obese patients with spontaneous labour between two oxytocin dosage regimens;Timepoint(s) of evaluation of this end point: At the end of follow-up for the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Compare the two oxytocin dosage regimens for: - Labour and delivery circumstances - Maternal complications - Foetal complications - Neonatal complications - Oxytocin side effects ;Timepoint(s) of evaluation of this end point: At the end of follow-up for the last patient | — |
Countries
France
Outcome results
None listed