Prophylactic Methylergonovine for Twin Cesarean

NCT05772156 | Completed Phase 4 Results FDA Drug

• 1 other identifier: AAAU3902
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Twin; Complicating Pregnancy; Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Change in Maternal Hemoglobin Level

  The change in maternal hemoglobin level as taken from blood samples. The change will be calculated from preoperative day 1 (baseline) to postoperative day 1.

  Baseline and Postoperative Day 1 (Approximately 48 hours)

Secondary Outcomes (18)

• Surgical Time

  Intraoperative (Approximately 24 hours)

• Estimated Blood Loss

  Intraoperative (Approximately 24 hours)

• Quantitative Blood Loss

  Intraoperative (Approximately 24 hours)

• Number of Participants With Postpartum Hemorrhage

  Intraoperative (Approximately 24 hours)

• Number of Participants Requiring Use of Uterotonics

  Intraoperative (Approximately 24 hours)

Study Arms (2)

Prophylactic methylergonovine

EXPERIMENTAL

Prophylactic methylergonovine 200mcg IM

Drug: Methylergonovine

Control group/placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Methylergonovine DRUG

Methylergonovine 200mcg Intramuscular (IM)

Also known as: Methergine

Prophylactic methylergonovine

Placebo DRUG

Matching saline placebo

Also known as: Saline

Control group/placebo

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Twin gestation
• Scheduled cesarean delivery (\>=34 weeks)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (8)

• Osterman M, Hamilton B, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2020. Natl Vital Stat Rep. 2021 Feb;70(17):1-50.

  PMID: 35157571 BACKGROUND

• Sheehan SR, Montgomery AA, Carey M, McAuliffe FM, Eogan M, Gleeson R, Geary M, Murphy DJ; ECSSIT Study Group. Oxytocin bolus versus oxytocin bolus and infusion for control of blood loss at elective caesarean section: double blind, placebo controlled, randomised trial. BMJ. 2011 Aug 1;343:d4661. doi: 10.1136/bmj.d4661.

  PMID: 21807773 BACKGROUND

• Blitz MJ, Yukhayev A, Pachtman SL, Reisner J, Moses D, Sison CP, Greenberg M, Rochelson B. Twin pregnancy and risk of postpartum hemorrhage. J Matern Fetal Neonatal Med. 2020 Nov;33(22):3740-3745. doi: 10.1080/14767058.2019.1583736. Epub 2019 Mar 5.

  PMID: 30836810 BACKGROUND

• Attilakos G, Psaroudakis D, Ash J, Buchanan R, Winter C, Donald F, Hunt LP, Draycott T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage following caesarean section: the results of a double-blind randomised trial. BJOG. 2010 Jul;117(8):929-36. doi: 10.1111/j.1471-0528.2010.02585.x. Epub 2010 May 19.

  PMID: 20482535 BACKGROUND

• Chaudhuri P, Banerjee GB, Mandal A. Rectally administered misoprostol versus intravenous oxytocin infusion during cesarean delivery to reduce intraoperative and postoperative blood loss. Int J Gynaecol Obstet. 2010 Apr;109(1):25-9. doi: 10.1016/j.ijgo.2009.11.009. Epub 2010 Jan 13.

  PMID: 20070961 BACKGROUND

• Senturk S, Kagitci M, Balik G, Arslan H, Kir Sahin F. The Effect of the Combined Use of Methylergonovine and Oxytocin during Caesarean Section in the Prevention of Post-partum Haemorrhage. Basic Clin Pharmacol Toxicol. 2016 May;118(5):338-43. doi: 10.1111/bcpt.12500. Epub 2015 Nov 15.

  PMID: 26449959 BACKGROUND

• Masse N, Dexter F, Wong CA. Prophylactic Methylergonovine and Oxytocin Compared With Oxytocin Alone in Patients Undergoing Intrapartum Cesarean Birth: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):181-186. doi: 10.1097/AOG.0000000000004857. Epub 2022 Jul 6.

  PMID: 35852267 BACKGROUND

• Horowitz E, Yogev Y, Ben-Haroush A, Rabinerson D, Feldberg D, Kaplan B. Routine hemoglobin testing following an elective Cesarean section: is it necessary? J Matern Fetal Neonatal Med. 2003 Oct;14(4):223-5. doi: 10.1080/jmf.14.4.223.225.

  PMID: 14738165 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications; Postpartum Hemorrhage

Interventions

Methylergonovine; Sodium Chloride

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ergonovine; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Intramuscular Methylergonovine to Decrease Blood Loss During Cesarean Delivery for Twins: A Triple-B
• Organization: NewYork-Presbyterian Hospital, Columbia University Irving Medical Center

hbg2115@cumc.columbia.edu

877-843-2229

Study Officials

• Mirella Mourad

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: March 7, 2023
• Primary Completion: March 3, 2024
• Study Completion: March 11, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Locations

US (1)