Phase 4
Completed N=66
Prophylactic Methylergonovine for Twin Cesarean
Twin; Complicating Pregnancy · postpartum hemorrhage
Source: ClinicalTrials.gov NCT05772156 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Change in Maternal Hemoglobin Level — 1.1; 2.1 g/dL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Maternal Hemoglobin Level |
1.1; 2.1 | — |
| SECONDARY Surgical Time |
62.0; 61.0 | — |
| SECONDARY Estimated Blood Loss |
800; 1000 | — |
| SECONDARY Quantitative Blood Loss |
891; 1017 | — |
| SECONDARY Number of Participants With Postpartum Hemorrhage |
6; 18 | — |
| SECONDARY Number of Participants Requiring Use of Uterotonics |
0; 6 | — |
| SECONDARY Number of Participants Requiring Use of Tranexamic Acid |
2; 7 | — |
| SECONDARY Number of Participants Requiring Use of Open-Label Methylergonovine |
0; 7 | — |
| SECONDARY Number of Participants Requiring Transfusion (Intraoperative) |
0; 0 | — |
| SECONDARY Number of Participants With Surgical or Radiological Interventions |
0; 0 | — |
| SECONDARY Number of Participants With Transfusion Related Acute Lung Injury (TRALI) |
0; 0 | — |
| SECONDARY Number of Participants Requiring Transfusion (6 Weeks) |
2; 4 | — |
| SECONDARY Number of Participants With Acute Elevation of Serum Creatinine |
0; 0 | — |
| SECONDARY Number of Postpartum Infectious Complications |
0; 2 | — |
| SECONDARY Number of Participants With Admission to the Intensive Care Unit |
0; 0 | — |
| SECONDARY Length of Stay |
4; 4 | — |
| SECONDARY Number of Participants Re-Admitted to the Hospital |
1; 3 | — |
| SECONDARY Apgar Scores |
8; 8; 9; 9 | — |
| SECONDARY Neonatal Intensive Care Unit (NICU) Admission |
19; 20 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05772156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.