Misoprostol+Oxytocin vs. Carbetocin in CS

NCT02786992 | Completed Phase 2

• 1 other identifier: AS1301
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.

Conditions

Cesarean Section

Keywords

Misoprostol; Oxytocin; Carbetocin; Prevention; Post-partum hemorrhage

Outcome Measures

Primary Outcomes (2)

• incidence of post-partum hemorrhage

  24 hours

• amount of blood loss

  24 hours

Secondary Outcomes (8)

• Number of participants needing extra uterotonic drug (10 IU oxytocin IVI)

  24 hours

• Number of participants needing hemostatic surgical interventions

  intra-operative

• Hemoglobin deficit in gm/dl

  24 hours

• APGAR score at 1 minute and 5 minutes

  1 minute and 5 minutes

• Number of participants with NICU admission

  24 hours

Study Arms (2)

Misoprostol + Oxytocin

ACTIVE COMPARATOR

400 ug sublingual misoprostol + 10 IU Oxytocin IVI

Drug: Misoprostol; Drug: Oxytocin; Drug: Placebo

Carbetocin

ACTIVE COMPARATOR

100 ug Carbetocin IV

Drug: Carbetocin; Drug: Placebo

Interventions

Misoprostol DRUG

Also known as: Mesotec, Mesotac

Misoprostol + Oxytocin

Oxytocin DRUG

Also known as: Syntocinon

Misoprostol + Oxytocin

Carbetocin DRUG

Also known as: Pabal

Carbetocin

Placebo DRUG

Carbetocin; Misoprostol + Oxytocin

Eligibility Criteria

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

You may qualify if:

• Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).

You may not qualify if:

• hypersensitivity to oxytocin, carbetocin or prostaglandins
• contraindication to prostaglandins (e.g. glaucoma)
• history of significant heart disease
• severe asthma
• epilepsy
• history or evidence of liver
• renal or vascular disease
• history of coagulopathy
• thrombocytopenia or anticoagulant therapy
• women with HELLP syndrome
• eclampsia
• women presenting by placental abruption
• contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol; Oxytocin; carbetocin

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)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 1, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

EG (1)