MedTrace Logo

Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2

NCT03957083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-06

No results posted yet for this study

Summary

Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH. Large doses of this drug are asociated with adverse effects like low blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. Various international bodies recommend varying and high doses of oxytocin in elective cesarean sections. A study performed at Mount Sinai Hospital showed that a much smaller dose of oxytocin is required (ED95 being 0.35IU). However, most of the women included in this study were below a body mass index (BMI) of 40kg/m2.

The investigators seek to find the best dose for patients with a BMI\>40kg/m2, as a higher dose may be needed in this population to contract the uterus adequately.

Conditions

Interventions

DRUG

Oxytocin

Oxytocin administered intravenously, over 1 minute following delivery of the fetal head

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Jose Carvalho, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2020-02-03
Completion
2020-02-04

Countries

  • Canada

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 NCT03957083 on ClinicalTrials.gov