Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour

NCT04760496 | Completed Phase 4

• 1 other identifier: 2020-002640-23
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 12

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.

Conditions

Obese; Oxytocin; Primiparous Women

Keywords

Obese; Primiparous women; Oxytocin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Length of labour phases

  Through study completion, an average of 1 month

• Arrest of labour

  Through study completion, an average of 1 month

• Interruption of oxytocin perfusion and causes

  through study completion, an average of 1 month

• Uterine hyper-stimulation

  Through study completion, an average of 1 month

• Mode of vaginal delivery

  Through study completion, an average of 1 month

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive oxytocin at 4 mIU/mL

Drug: Oxytocin 4 mIU/mL

Control group

ACTIVE COMPARATOR

The control group will receive oxytocin at 2 mIU/mL

Drug: Oxytocin 2 mIU/mL

Interventions

Oxytocin 4 mIU/mL DRUG

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

Experimental group

Oxytocin 2 mIU/mL DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (12)

CHU d'Angers

Angers, France

Location

CHU de Bordeaux (Pellegrin)

Bordeaux, France

Location

Hôpital Béclère

Clamart, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHU de Montpellier

Montpellier, France

Location

CHU de Nimes

Nîmes, France

Location

Hôpital Cochin Port Royal

Paris, France

Location

Hôpital Tenon

Paris, France

Location

CHU de Poissy St Germain

Poissy, France

Location

CHU de Saint Etienne

Saint-Etienne, France

Location

CHU de Strasbourg (Centre Médico Chirurgical et Obstétrical)

Schiltigheim, France

Location

CHU de Strasbourg (Hôpital de Hautepierre)

Strasbourg, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra BENACHI, PHD, MD

  Antoine Béclère Hospital, APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 18, 2021
• Study Start: October 2, 2021
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-08

Locations

FR (12)