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 Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section
Status
Unknown
Phase
Not applicable
Enrollment
400
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
Purpose to evaluates the effects of oxytocin infusion with or without intravenous tranexamic acid (TA) in comparison with Carbetocin for prevention of postpartum hemorrhage at a cesarean section with one or more risk factor for postpartum hemorrhage.
Full detailed description
Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries. The risk of PPH is much higher for women undergoing cesarean delivery (CD). 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. 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 is to compare the effectiveness of combined tranexamic acid (TA) and oxytocin infusion with intravenous carbetocin for prevention of PPH in patients with risk factors during cesarean section.
Interventions
Treatment arms and agents.
DRUG
oxytocin
20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
DRUG
TA
2 ampoules of TA in 100 ml saline by slow infusion
DRUG
placebo to carbetocin
placebo ampoule to carbetocin 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
placebo to TA
2 placebo ampoules to TA in 100 ml saline by slow infusion
DRUG
placebo to oxytocin
two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
Timeline
From registration to results.
First posted
Dec 17, 2018
Study start
Jan 1, 2019
Primary completion
Mar 30, 2021
Study completion
May 1, 2021
Results posted
Not reported
Registry updated
Feb 15, 2019
Outcomes
What the study measures.
Primary outcomes
The number of the patient need of additional pharmacological uterotonic.
Time frame · 24 hours post operative
calculate the number of the patient need of additional pharmacological uterotonic.
Secondary outcomes
estimation of intraoperative blood loss (ml)
Time frame · during the operation
measure Intraoperative blood loss in ml by gravimetric methods
amount of postoperative blood loss
Time frame · 24 hours post operative
measure amount of blood loss post operative in ml by gravimetric methods
number of patient with postpartum hemorrhage
Time frame · 24 hours post operative
calculation of the number of the patients with blood loss \>1000 ml
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- FEMALE
- Healthy volunteers
- No
Inclusion Criteria: * Women who undergo elective cesarean section with one or more risk factors for PPH were the candidates for participation * With fetal macrosomia, polyhydramnios, low insertion of the placenta, multiple gestations, prolonged labor, chorioamnionitis, past history of PPH, diabetes and high parity (5 previous deliveries). Exclusion Criteria: * suspected coagulopathy, * history of coronary artery disease or hypertension, * women with a history of hypersensitivity to carbetocin, TA or oxytocin * general anesthesia, and * PPH due to causes other than uterine atony.
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
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Not yet recruiting
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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
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