drugset / Trial / NCT04025658

Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy

NCT04025658

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. Large doses of this drug are associated with adverse effects like lower 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 doses of oxytocin is required (ED95 being 0.35IU). Women who had twins were excluded from this study. It is known that women with a twin pregnancy have a higher risk of poor tone and postpartum hemorrhage. The investigators seek to find the best dose of oxytocin for the patients with a twin pregnancy. A higher dose may be needed to contract the uterus adequately.

Timeline

Start
2019-08-06
Primary completion
2021-09-07
Completion
2021-09-08

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

No indication recorded.