Efficacy of Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Blood Loss During Cesarean Section

NCTNCT05664659Other idFMASU MS 211/2022

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 90 participants (actual)
Sponsor: Ain Shams Maternity Hospital · Other
Design: Randomized · Double masking
Countries: 1 country
Egypt
Start: 20 Dec 2022
Primary completion: 30 Apr 2023
Completion: 20 May 2023
First posted: 27 Dec 2022
Last update posted: 24 Jul 2023
Conditions: Blood Loss, Surgical · Intrapartum Hemorrhage

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024

Ph 4
Efficacy of Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Blood Loss During Cesarean Section
NCT05664659
20 Dec 2022 to 20 May 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of this clinical trial is to test if carbetocin is as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section. The main question it aims to answer is: \* Is carbetocin as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section? Researchers will compare 2 groups: * women receiving Oxytocin plus Misoprostol; * women receiving Carbetocin as regards: * estimated blood loss

Interventions

Oxytocin + misoprostolDrug
CarbetocinDrug

Arms2

Active comparator
Oxytocin+Misoprostol
Patients in this group will receive 600 micrograms misoprostol rectally immediately before sterilization plus 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution immediately after delivery of the fetus.
Experimental
Carbetocin
Patients in this group will receive 100ug Carbetocin by slow IV infusion (over one minute) intra-operative immediately after delivery of the fetus.

Primary outcomes1

Outcomes the sponsor listed as primary.

estimated blood loss in millimeters
Time frame · calculated once at the end of the CS
Registry description
estimated blood lost during the cesarean section (CS)

Secondary outcomes(1)

drop in hemoglobin
Time frame · calculated once after 24hours of the CS
Registry description
Difference in Hemoglobin level before and after CS

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Pregnant women planning to deliver by CS. * Age between 18-40. * Gestational age: (36-42 weeks). Exclusion Criteria: 1. Women in active labour. 2. Rupture of membranes more than 24 hours \&/or intraamniotic infection. 3. Suspected extensive adhesions eg: more than P3CS, endometriosis, previous pelvic surgery. 4. Antepartum hemorrhage and abnormal placentation e.g.: low lying placenta, placenta previa, placenta accreta. 5. Major intrapartum hemorrhage more than 1000 ml. 6. History of postpartum hemorrhage. 7. Anemia (Hb level less than 10g/dl). 8. Uterine overdistention eg: polyhydramnios, macrosomic baby, multiple pregnancy. 9. Known allergy to any of misoprostol, oxytocin, carbetocin. 10. Known medical disorders: Diabetes Mellitus, hypertensive disorders, Systemic Lupus Erythematosus. 11. Known coagulopathy problem. 12. Contraindication \&/or refusal to spinal anesthesia.

PepBank is a research reference. Talk to a doctor before you use any peptide.