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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04760496
Other study ID # 2020-002640-23
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 2, 2021
Est. completion date November 2, 2023

Study information

Verified date June 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Alexandra BENACHI, PHD, MD
Phone +33145374476
Email alexandra.benachi@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 882
Est. completion date November 2, 2023
Est. primary completion date October 2, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oxytocin 4 mIU/mL
Oxytocin at 4 mIU/mL administrated by IV infusion controlled by pump or electric syringe.
Oxytocin 2 mIU/mL
Oxytocin at 2 mIU/mL administrated by IV infusion controlled by pump or electric syringe.

Locations

Country Name City State
France CHU d'Angers Angers
France Hôpital Jean Verdier Bondy
France CHU de Bordeaux (Pellegrin) Bordeaux
France Hôpital Béclère Clamart
France Hôpital Bicêtre Le Kremlin Bicêtre
France CHRU Lille Lille
France CHU de Montpellier Montpellier
France CHU de Nimes Nîmes
France Hôpital Cochin Port Royal Paris
France Hôpital Tenon Paris
France CHU de Poissy St Germain Poissy
France CHU de Saint Etienne Saint-Étienne
France CHU de Strasbourg (Centre Médico Chirurgical et Obstétrical) Schiltigheim
France CHU de Strasbourg (Hôpital de Hautepierre) Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of caesarean section during labour 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.
through study completion, an average of 1 month
Secondary Length of labour phases Length of labour phases is measured in minutes (from 2 cm of dilation until delivery) Through study completion, an average of 1 month
Secondary Arrest of labour It will be evaluated if there is two or more hours without cervical dilation (yes/no) Through study completion, an average of 1 month
Secondary Interruption of oxytocin perfusion and causes Interruption of oxytocin perfusion (yes/no) and causes (foetal heart anomalies / uterine hyperkinesia / uterine hypertonia / other) through study completion, an average of 1 month
Secondary Uterine hyper-stimulation Uterine hyper-stimulation (more than 5 uterine contractions per 10 min) Through study completion, an average of 1 month
Secondary Mode of vaginal delivery Spontaneous or operative delivery.If operative vaginal delivery: indication Through study completion, an average of 1 month
Secondary Reason for the caesarean section foetal heart anomalies / labour arrest / other through study completion, an average of 1 month
Secondary Post-partum haemorrhage 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. Through study completion, an average of 1 month
Secondary Maternal blood transfusion Maternal blood transfusion (yes/no) (for the duration of the hospitalization) Through study completion, an average of 1 month
Secondary Volume of oxytocin infusion Volume of oxytocin infusion (mL/H) Through study completion, an average of 1 month
Secondary Oxytocin side effects nausea, vomiting, headaches, increased or decreased heart rate, allergic reaction, skin rash Through study completion, an average of 1 month
Secondary Foetal complications 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 sign
Through study completion, an average of 1 month
Secondary Neonatal complications 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)
Through study completion, an average of 1 month
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