Clinical trial NCT04760496: Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour
Official title: Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour. A Double-blind, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obese
Primiparous Women
Oxytocin
Keywords: Obese
Primiparous women
Oxytocin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 882
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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/mL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of caesarean section during labour
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Length of labour phases
timeFrame: Through study completion, an average of 1 month
measure: Arrest of labour
timeFrame: Through study completion, an average of 1 month
measure: Interruption of oxytocin perfusion and causes
timeFrame: through study completion, an average of 1 month
measure: Uterine hyper-stimulation
timeFrame: Through study completion, an average of 1 month
measure: Mode of vaginal delivery
timeFrame: Through study completion, an average of 1 month
measure: Reason for the caesarean section
timeFrame: through study completion, an average of 1 month
measure: Post-partum haemorrhage
timeFrame: Through study completion, an average of 1 month
measure: Maternal blood transfusion
timeFrame: Through study completion, an average of 1 month
measure: Volume of oxytocin infusion
timeFrame: Through study completion, an average of 1 month
measure: Oxytocin side effects
timeFrame: Through study completion, an average of 1 month
measure: Foetal complications
timeFrame: Through study completion, an average of 1 month
measure: Neonatal complications
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Bondy
country: France
facility: Hôpital Jean Verdier
city: Bordeaux
country: France
facility: CHU de Bordeaux (Pellegrin)
city: Clamart
country: France
facility: Hôpital Béclère
city: Le Kremlin Bicêtre
country: France
facility: Hôpital Bicêtre
city: Lille
country: France
facility: CHRU Lille
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de Nimes
city: Paris
country: France
facility: Hôpital Cochin Port Royal
city: Paris
country: France
facility: Hôpital Tenon
city: Poissy
country: France
facility: CHU de Poissy St Germain
city: Saint-Étienne
country: France
facility: CHU de Saint Etienne
city: Schiltigheim
country: France
facility: CHU de Strasbourg (Centre Médico Chirurgical et Obstétrical)
city: Strasbourg
country: France
facility: CHU de Strasbourg (Hôpital de Hautepierre)
Study officials:
affiliation: Antoine Béclère Hospital, APHP
name: Alexandra BENACHI, PHD, MD
role: PRINCIPAL_INVESTIGATOR
References: