Prophylactic Methylergonovine for Twin Cesarean

• Status: Not yet recruiting
• Trial end date: 2024-01-30
• Target enrollment: 0
• Participant gender: Female

Summary

Obstetrical hemorrhage (excessive bleeding related to pregnancy) is a leading cause of maternal morbidity (disease or symptom of disease) and mortality (death) worldwide with a significantly higher frequency and severity following cesarean delivery. Twin gestations (twin pregnancy) are at particularly higher risk for postpartum hemorrhage, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery.

The purpose of this study is to understand the effect of prophylactic methylergonovine on blood loss in scheduled twin pregnancy cesarean deliveries. Participants will be randomized (like tossing a coin) to Methylergonovine (investigational drug) or water with salt (saline) (placebo). Methylergonovine or saline will be given as an injection immediately after delivery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Methylergonovine

Criteria

Inclusion Criteria:

• Twin gestation

• Scheduled cesarean delivery (>=34 weeks)

Exclusion criteria:

• Patients with known hypertensive disease: history of chronic hypertension, gestational hypertension or preeclampsia with or without severe features

• Use of protease inhibitors given known vasoconstrictive side effects with concomitant methylergonovine administration

• Hypersensitivity to methylergonovine or any of the ingredients

• Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism

• Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis

• Non-elective cesarean delivery