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

NCT05664659 | Completed Phase 4 DMC

• 1 other identifier: FMASU MS 211/2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Loss, Surgical; Intrapartum Hemorrhage

Keywords

estimated blood loss; carbetocin; oxytocin; misoprostol

Outcome Measures

Primary Outcomes (1)

• estimated blood loss in millimeters

  estimated blood lost during the cesarean section (CS)

  calculated once at the end of the CS

Secondary Outcomes (1)

• drop in hemoglobin

  calculated once after 24hours of the CS

Study Arms (2)

Oxytocin+Misoprostol

ACTIVE COMPARATOR

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.

Drug: Oxytocin + misoprostol

Carbetocin

EXPERIMENTAL

Patients in this group will receive 100ug Carbetocin by slow IV infusion (over one minute) intra-operative immediately after delivery of the fetus.

Drug: Carbetocin

Interventions

Oxytocin + misoprostol DRUG

600 micrograms misoprostol rectally 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution

Oxytocin+Misoprostol

Carbetocin DRUG

100 micrograms carbetocin

Carbetocin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women planning to deliver by CS.
• Age between 18-40.
• Gestational age: (36-42 weeks).

You may not qualify if:

• Women in active labour.
• Rupture of membranes more than 24 hours \&/or intraamniotic infection.
• Suspected extensive adhesions eg: more than P3CS, endometriosis, previous pelvic surgery.
• Antepartum hemorrhage and abnormal placentation e.g.: low lying placenta, placenta previa, placenta accreta.
• Major intrapartum hemorrhage more than 1000 ml.
• History of postpartum hemorrhage.
• Anemia (Hb level less than 10g/dl).
• Uterine overdistention eg: polyhydramnios, macrosomic baby, multiple pregnancy.
• Known allergy to any of misoprostol, oxytocin, carbetocin.
• Known medical disorders: Diabetes Mellitus, hypertensive disorders, Systemic Lupus Erythematosus.
• Known coagulopathy problem.
• Contraindication \&/or refusal to spinal anesthesia.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Oxytocin; Misoprostol; carbetocin

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Mohamed SE Sweed, MD

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Eligible patients will be randomised \& allocated into 2 groups (A) \& (B). Randomization will be done using computer generated list. Allocation \& concealment will be done using sealed envelopes prepared according to computer generated list into ratio 1:1.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: December 20, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 20, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be available after completion of the study and publishing the results, for 5 years therafter.
• Access Criteria: requests for data are to be sent at: raneyah@gmail.com

Locations

EG (1)