Multimodal Uterotonics at the Time of Cesarean Section in Laboring Patients

NCT03904446 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201904756
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Uterine Atony With Hemorrhage

Keywords

Methergine; Uterine Atony

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Need for Additional Uterotonics (Methylergonovine, Carboprost, Misoprostol)

  Categorical Variable (Yes/No) - Depending on whether patients required additional uterotonic agents the outcome measure will be yes or no.

  Assessed from the time of cesarean section until 24 hours postdelivery

Secondary Outcomes (4)

• Quantitative Blood Loss

  Quantitative Blood Loss is measured at the completion of the cesarean delivery, an average of 2 hours

• The Difference Between the Preoperative and Postoperative (Postpartum Day 1) Hemoglobin Values

  Preoperative hemoglobin level is collected on arrival to labor and delivery prior to the cesarean section, postoperative hemoglobin is collected on postoperative day one.

• Number of Patients With Unsatisfactory Uterine Tone 4 Min Following Delivery as Assessed by the Obstetrician

  Obstetricians will assess the uterine tone 4 minutes following delivery of the infant

• The Number of Patients Who Required a Blood Transfusion During the Delivery Hospitalization

  The need for a blood transfusion during the cesarean section up until hospital discharge (which is typically postpartum day number 3 for patients undergoing cesarean delivery)

Study Arms (2)

Methylergonovine 0.2 mg

EXPERIMENTAL

Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine

Drug: Methylergonovine

Placebo (Normal Saline)

PLACEBO COMPARATOR

Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular

Drug: Normal Saline (placebo)

Interventions

Methylergonovine DRUG

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

Also known as: Methergine

Methylergonovine 0.2 mg

Normal Saline (placebo) DRUG

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

Also known as: Saline

Placebo (Normal Saline)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Yes. Pregnant women are the only eligible subjects.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Laboring patients who undergo a cesarean section

You may not qualify if:

• Placenta/Uterine Abnormalities
• Chronic Hypertension, Gestational Hypertension, Preeclampsia
• HIV/AIDS on protease inhibitors
• History of Coronary Artery Disease
• History of Hypersensitivity to Methylergonovine

Sponsors & Collaborators

• Cynthia Wong: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

• 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

• Lavoie A, McCarthy RJ, Wong CA. The ED90 of prophylactic oxytocin infusion after delivery of the placenta during cesarean delivery in laboring compared with nonlaboring women: an up-down sequential allocation dose-response study. Anesth Analg. 2015 Jul;121(1):159-164. doi: 10.1213/ANE.0000000000000781.

  PMID: 25902327 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 DERIVED

MeSH Terms

Conditions

Uterine Inertia

Interventions

Methylergonovine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Dystocia; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Cynthia A. Wong, MD
• Organization: University of Iowa

cynthia-wong@uiowa.edu

13193563868

Study Officials

• Nicole M Masse, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician-Professor-DEO

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: June 8, 2019
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: August 1, 2022
• Results First Posted: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)