Phase 4
Completed N=160
Multimodal Uterotonics at the Time of Cesarean Section in Laboring Patients
Uterine Atony With Hemorrhage
Source: ClinicalTrials.gov NCT03904446 ↗
Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol) — 80; 80 Participants
◆ Published Evidence
Emerging
6citations · ~2 / year
Prophylactic Methylergonovine and Oxytocin Compared With Oxytocin Alone in Patients Undergoing Intrapartum Cesarean Birth: A Randomized Controlled Trial.
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).
Linked Publications
-
Prophylactic Methylergonovine and Oxytocin Compared With Oxytocin Alone in Patients Undergoing Intrapartum Cesarean Birth: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol) |
80; 80 | — |
| SECONDARY Quantitative Blood Loss |
967; 1315 | — |
| SECONDARY The Difference Between the Preoperative and Postoperative (Postpartum Day 1) Hemoglobin Values |
2.36; 2.91 | — |
| SECONDARY Number of Patients With Unsatisfactory Uterine Tone 4 Min Following Delivery as Assessed by the Obstetrician |
64; 33 | — |
| SECONDARY The Number of Patients Who Required a Blood Transfusion During the Delivery Hospitalization |
4; 18 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age
- Laboring patients who undergo a cesarean section
Exclusion Criteria
- Placenta/Uterine Abnormalities
- Chronic Hypertension, Gestational Hypertension, Preeclampsia
- HIV/AIDS on protease inhibitors
- History of Coronary Artery Disease
- History of Hypersensitivity to Methylergonovine
Data sourced from ClinicalTrials.gov (NCT03904446) and the linked publication. 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.