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CompletedNCT02786992CSUpdated Jul 8, 2020

Misoprostol+Oxytocin vs. Carbetocin in CS

A Phase 2/3 interventional study of Misoprostol and Oxytocin in Cesarean Section, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Ain Shams University · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cesarean Section

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Keywords

  • Misoprostol
  • Oxytocin
  • Carbetocin
  • Prevention
  • Post-partum hemorrhage
03

In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's enrollment of 600 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
600 participants (actual)

Study arms

  • Active comparator
    Misoprostol + Oxytocin

    400 ug sublingual misoprostol + 10 IU Oxytocin IVI

    Drug: Misoprostol · Drug: Oxytocin · Drug: Placebo

  • Active comparator
    Carbetocin

    100 ug Carbetocin IV

    Drug: Carbetocin · Drug: Placebo

Interventions

  • DrugMisoprostol

    Also known as: Mesotec, Mesotac

  • DrugOxytocin

    Also known as: Syntocinon

  • DrugCarbetocin

    Also known as: Pabal

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. incidence of post-partum hemorrhage

    Time frame: 24 hours

  2. amount of blood loss

    Time frame: 24 hours

Secondary outcomes

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

    An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml.

    Time frame: 24 hours

  2. Number of participants needing hemostatic surgical interventions

    Time frame: intra-operative

  3. Hemoglobin deficit in gm/dl

    difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl

    Time frame: 24 hours

  4. APGAR score at 1 minute and 5 minutes

    Time frame: 1 minute and 5 minutes

  5. Number of participants with NICU admission

    Time frame: 24 hours

  6. Drug side effects

    Time frame: 24 hours

  7. Time till resuming bowel habits

    Time of passing gas will be recorded how many hours post-operative

    Time frame: 24 hours

  8. hematocrit deficit in %

    difference between pre-operative and 24 hours post-operative hematocrit in %

    Time frame: 24 hours

07

Study locations

1 site
  • Ain Shams University Maternity Hospital
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02786992
Lead sponsor
Ain Shams University
Responsible party
Mohamed S Sweed, MD (Dr, Ain Shams University) — Principal investigator
First posted
Jun 1, 2016
Start date
May 2016
Primary completion
Jan 2020
Completion
Jan 2020
Last update
Jul 8, 2020
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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