Status:
COMPLETED
Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions:
Postpartum Hemorrhage
Twin
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief 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 effe...
Detailed Description
Postpartum hemorrhage (PPH) is one of the leading causes of death during childbirth and accounts for an estimated 140,000 deaths per year worldwide. Furthermore, recent evidence has shown that the rat...
Eligibility Criteria
Inclusion
- Twin pregnancy
- Elective cesarean delivery under regional anesthesia
- Gestational age ≥36 weeks
- No known additional risk factors for postpartum hemorrhage
- Written informed consent to participate in this study
Exclusion
- Refusal to give written informed consent
- Allergy or hypersensitivity to oxytocin
- Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI \>40
- Hepatic, renal, and vascular disease
- Use of general anesthesia prior to the administration of the study drug
Key Trial Info
Start Date :
August 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04025658
Start Date
August 6 2019
End Date
September 8 2021
Last Update
January 28 2022
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5