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Completed

NCT Number: NCT02786992

Misoprostol+Oxytocin vs. Carbetocin in CS

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.

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Key information

Conditions

Cesarean Section Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Misoprostol

Drug

Other names: Mesotec, Mesotac

Oxytocin

Drug

Other names: Syntocinon

Carbetocin

Drug

Other names: Pabal

Placebo

Drug

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)

    Time frame: 24 hours

    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.

  2. Number of participants needing hemostatic surgical interventions

    Time frame: intra-operative

  3. Hemoglobin deficit in gm/dl

    Time frame: 24 hours

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

  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 frame: 24 hours

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

  8. hematocrit deficit in %

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Adjuvant Use of Misoprostol and Oxytocin vs. Carbetocin for the Prevention of Post-partum Hemorrhage in Elective Cesarian Section

Acronym: CS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2016
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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