DRUG
carbetocin
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
Carbetocin Versus Buccal Misoprostol Plus IV Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section
Status
Completed
Phase
Not applicable
Enrollment
400
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
Eligible and consenting participants were randomized via a computer-generated random number sequence into one of two groups: one group received a pre-prepared sealed and opaque packet containing 400 μg of misoprostol (2 tablets of 200 μg), 2 ampoules of TA. The other group received similar packets containing two placebo tablets, two placebo ampoules (distilled water) and separate carbetocin ampoule (100 μg) for slow intravenous injection. The misoprostol and placebo tablets were similar in size, shape, and color, and ampoules of TA and carbetocin will be also similar to placebo. Randomization was done by the resident doctors immediately before transfer to the theater, whereas preparation of packets and confidential record maintenance was done by the labor room nursing staff. 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. .
Interventions
Treatment arms and agents.
DRUG
Tranexamic Acid
1 gm tranexamic acid in 100 mL of intravenous solution infusion over 15 min.
DRUG
misoprostol
Group 2 400 μg buccal misoprostol (2 tablets of 200 μg) will be given after spinal anesthesia and few minutes before skin incision
Timeline
From registration to results.
First posted
Oct 18, 2018
Study start
Dec 1, 2018
Primary completion
May 30, 2020
Study completion
Aug 1, 2020
Results posted
Not reported
Registry updated
Aug 5, 2020
Outcomes
What the study measures.
Primary outcomes
Number of participants require additional pharmacological uterotonic.
Time frame · ist 24 hours post operative
Number of participants need extra uterotonic
Secondary outcomes
intraoperative blood loss
Time frame · during the operation
amount of blood loss during cesarean section
post operative blood loss
Time frame · 24 hours post operative
amount of blood loss after cesarean section
Number of participants need for blood transfusion
Time frame · 24 hours post operative
Number of participants needed for transfusion
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 45 Years
- Sex
- FEMALE
- Healthy volunteers
- No
Inclusion Criteria: * pregnant women scheduled for an elective cesarean section with at least one risk factor for postpartum hemorrhage Exclusion Criteria: * suspected coagulopathy * women refuse to participate * emergent cesarean section * allergy to misoprostol or tranexamic acid or carbetocin * known deep venous thrombosis * general anesthesia
Study locations
1 registered sites.
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Aswan University
Aswān, Egypt
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Carbetocin.
NCT IDStudyPhase / statusEnrollmentUpdated
The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy
Alex Ekwueme Federal University Teaching Hospital · Blood Loss, Surgical
Early Phase 1
Not yet recruiting
900
2026-07
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Mansoura University · Postpartum Hemorrhage · Uterine Atony
Phase 4
Not yet recruiting
332
2026-06
Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage
Sheba Medical Center · Postpartum Hemorrhage · Twin Pregnancy
Phase 4
Recruiting
120
2026-05
Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage
Not applicable
Recruiting
32
2026-04
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Post Partum Hemorrhage
Not applicable
Recruiting
160
2026-04
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage (Primary)
Not applicable
Recruiting
120
2026-04
Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients
Ankara Etlik City Hospital · Postpartum Hemorrhage \(PPH\)
Not applicable
Completed
300
2026-02
Carbetocin Myocardium Trial 2014 Part 2
Oslo University Hospital · Pregnancy Complications
Phase 4
Completed
240
2026-02
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.