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

NCT04760496 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 443

Last updated 2025-12-26

No results posted yet for this study

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
  • Primiparous Women
  • Oxytocin

Interventions

DRUG

Oxytocin 4 mIU/mL

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

DRUG

Oxytocin 2 mIU/mL

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Alexandra BENACHI, PHD, MD · Antoine Béclère Hospital, APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-02
Primary Completion
2024-12-30
Completion
2025-01-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760496 on ClinicalTrials.gov