CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 160 enrolled
Drug / intervention
Methylergonovine +1 moredrug
Likely dose
Methylergonovine 0.2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03904446
NCT03904446Phase 4Completed

A Randomized Controlled Trial to Assess the Effectiveness of Multimodal Prophylactic Uterotonics in Patients Undergoing Non-Elective Cesarean Sections After a Trial of Labor

Cynthia Wong·interventional·Posted Apr 5, 2019·Updated Aug 1, 2022

In Brief

A Phase 4 clinical trial evaluating Methylergonovine and Normal Saline (placebo) for Uterine Atony With Hemorrhage. Completed, enrolled 160 participants across 1 site.

Detailed Summary

Postpartum hemorrhage remains a leading cause of maternal morbidity and mortality worldwide, even in high income countries. Uterine atony is estimated to cause 70-80% of postpartum hemorrhage. Prolonged labor and augmented labor are known risk factors for postpartum hemorrhage. In attempts to reduce the incidence of postpartum hemorrhage, particularly in patients with known risks factors, it is essential to optimize preventative practices in order to reduce the rates postpartum hemorrhage. Although oxytocin is considered the first line therapy for preventing and treating uterine atony, early consideration of additional prophylactic uterotonic agents may be indicated in women with prior oxytocin exposure given oxytocin receptor desensitization and down regulation. As such, investigators sought to examine whether multimodal prophylactic uterotonics (standard oxytocin + methylergonovine), in patients who are increased risk of developing postpartum hemorrhage (specifically laboring patients who ultimately require a cesarean section) would benefit from the addition of prophylactic uterotonics. The clinical rational for administration of multimodal prophylactic uterotonics at the time of cesarean delivery in laboring patients is three-fold: to decrease the incidence of uterine atony, to decrease the incidence of postpartum hemorrhage, decrease the number of uterotonics required at the time of cesarean section. The primary outcome will be to evaluate the need for additional uterotonic agents (Methylergonovine, Carboprost, Misoprostol) at the time of delivery. Secondary outcomes will include the incidence of postpartum hemorrhage (quantitative blood loss \>1 liter), surgical assessment of uterine tone four minutes following delivery of the placenta, preoperative and postoperative hemoglobin, the need for a blood transfusion, intensive care unit admission, uterine infection (endometritis).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 5, 2019
Enrollment StartJun 8, 2019
Primary CompletionFeb 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.2 years ago

Interventions

Methylergonovinedrug

0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.

Normal Saline (placebo)drug

1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion