drugset / Trial / NCT03957083

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

NCT03957083

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxytocin Peptide 0.5 iu Intravenous
Comparator Oxytocin Peptide 1 iu Intravenous
Comparator Oxytocin Peptide 2 iu Intravenous
Comparator Oxytocin Peptide 3 iu Intravenous
Comparator Oxytocin Peptide 4 iu Intravenous
Comparator Oxytocin Peptide 5 iu Intravenous

Indications