Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour
- Conditions
- OxytocinObesePrimiparous Women
- Interventions
- Registration Number
- NCT04760496
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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 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.
- 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, 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 or induced 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 or induced 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 882
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Oxytocin 4 mIU/mL The experimental group will receive oxytocin at 4 mIU/mL Control group Oxytocin 2 mIU/mL The control group will receive oxytocin at 2 mIU/mL
- Primary Outcome Measures
Name Time Method Rate of caesarean section during labour through study completion, an average of 1 month The decision of caesarean section is made by the responsible obstetrician in charge of the patient, he or she will be blinded of the patient's group (oxytocin dosage) to avoid differential indication for caesarean section.
Therefore, the decision to perform (or not) a caesarean section will be only based on foetal/maternal criteria, independently of oxytocin dosage.
- Secondary Outcome Measures
Name Time Method Length of labour phases Through study completion, an average of 1 month Length of labour phases is measured in minutes (from 2 cm of dilation until delivery)
Arrest of labour Through study completion, an average of 1 month It will be evaluated if there is two or more hours without cervical dilation (yes/no)
Interruption of oxytocin perfusion and causes through study completion, an average of 1 month Interruption of oxytocin perfusion (yes/no) and causes (foetal heart anomalies / uterine hyperkinesia / uterine hypertonia / other)
Uterine hyper-stimulation Through study completion, an average of 1 month Uterine hyper-stimulation (more than 5 uterine contractions per 10 min)
Mode of vaginal delivery Through study completion, an average of 1 month Spontaneous or operative delivery.If operative vaginal delivery: indication
Reason for the caesarean section through study completion, an average of 1 month foetal heart anomalies / labour arrest / other
Post-partum haemorrhage Through study completion, an average of 1 month Post-partum haemorrhage (yes/no) and its volume (mL). Post-partum haemorrhage is defined as blood lost ≥ 500 mL in the 2 hours after birth.
Maternal blood transfusion Through study completion, an average of 1 month Maternal blood transfusion (yes/no) (for the duration of the hospitalization)
Volume of oxytocin infusion Through study completion, an average of 1 month Volume of oxytocin infusion (mL/H)
Oxytocin side effects Through study completion, an average of 1 month nausea, vomiting, headaches, increased or decreased heart rate, allergic reaction, skin rash
Foetal complications Through study completion, an average of 1 month * Foetal heart rate anomalies requiring second-line monitoring (as pH/lactate blood test at scalp) or emergency delivery (yes / no)
* Appearance of meconium (yes / no)
* Chorioamnionitis (yes/no): defined as the combination of 2 of the next 3 signs: maternal fever more than 38°5 during labour and/or foetal heart tachycardia and/or biological infection signNeonatal complications Through study completion, an average of 1 month * Apgar score at 5 min
* Umbilical arterial cord pH
* Neonatal resuscitation (yes / no): defined by at least artificial ventilation
* Transfer to neonatal care unit (yes / no)
Trial Locations
- Locations (14)
Hôpital Tenon
🇫🇷Paris, France
CHU de Poissy St Germain
🇫🇷Poissy, France
CHU de Saint Etienne
🇫🇷Saint-Étienne, France
CHU de Montpellier
🇫🇷Montpellier, France
CHU de Bordeaux (Pellegrin)
🇫🇷Bordeaux, France
CHU de Strasbourg (Centre Médico Chirurgical et Obstétrical)
🇫🇷Schiltigheim, France
CHU de Strasbourg (Hôpital de Hautepierre)
🇫🇷Strasbourg, France
CHU d'Angers
🇫🇷Angers, France
CHU de Nimes
🇫🇷Nîmes, France
Hôpital Jean Verdier
🇫🇷Bondy, France
Hôpital Béclère
🇫🇷Clamart, France
CHRU Lille
🇫🇷Lille, France
Hôpital Cochin Port Royal
🇫🇷Paris, France
Hôpital Bicêtre
🇫🇷Le Kremlin Bicêtre, France