Carbetocin Versus Buccal Misoprostol Plus IV Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section

NCT03710317 | Completed

• 1 other identifier: aswu/274/7/18
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond our reach unless we prioritize the prevention and treatment of postpartum hemorrhage(PPH) in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) and in the third stage of labor for vaginal delivery has become essential to diminish the risk of PPH and improve maternal safety. Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer. Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CS has not been investigated as much. The buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration. Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as a single-dose injection; intravenously administered carbetocin has a half-life of approximately 40 min. A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min and persists for an average of 60 min following injection. The aim of this study was to compare the effectiveness of combined buccal misoprostol and IV tranexamic acid (TA)with intravenous carbetocin for prevention of PPH in patients with risk factors during cesarean section.

Conditions

Cesarean Section Complications

Keywords

cesarean section; tranexamic acid; postpartum hemorrhage; buccal misoprostol; carbetocin

Outcome Measures

Primary Outcomes (1)

• Number of participants require additional pharmacological uterotonic.

  Number of participants need extra uterotonic

  ist 24 hours post operative

Secondary Outcomes (3)

• intraoperative blood loss

  during the operation

• post operative blood loss

  24 hours post operative

• Number of participants need for blood transfusion

  24 hours post operative

Study Arms (2)

carbetocin

ACTIVE COMPARATOR

100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby

Drug: carbetocin

Tranexamic acid plus misoprostol

EXPERIMENTAL

400 μg buccal misoprostol (2 tablets of 200 μg) will be given after spinal anesthesia and few minutes before skin incision in addition to 1 gm tranexamic acid in 100 mL of intravenous solution infusion over 15 min.

Drug: Tranexamic Acid; Drug: misoprostol

Interventions

carbetocin DRUG

100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby

Also known as: Active Comparator

carbetocin

Tranexamic Acid DRUG

1 gm tranexamic acid in 100 mL of intravenous solution infusion over 15 min.

Also known as: Experimental

Tranexamic acid plus misoprostol

misoprostol DRUG

Group 2 400 μg buccal misoprostol (2 tablets of 200 μg) will be given after spinal anesthesia and few minutes before skin incision

Also known as: expremental

Tranexamic acid plus misoprostol

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: pregnant women scheduled for an elective cesarean section with at least one risk factor for postpartum hemorrhage
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women scheduled for an elective cesarean section with at least one risk factor for postpartum hemorrhage

You may not qualify if:

• suspected coagulopathy
• women refuse to participate
• emergent cesarean section
• allergy to misoprostol or tranexamic acid or carbetocin
• known deep venous thrombosis
• general anesthesia

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin; Tranexamic Acid; Misoprostol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: a double-blinded randomized placebo-controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study drug administration Group 1 100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby Group 2 400 μg buccal misoprostol (2 tablets of 200 μg) will be given after spinal anesthesia and few minutes before skin incision in addition to 1 gm tranexamic acid in 100 mL of intravenous solution infusion over 15 min.

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: October 18, 2018
• Study Start: December 1, 2018
• Primary Completion: May 30, 2020
• Study Completion: August 1, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)