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Completed

NCT Number: NCT03693599

Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

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Key information

Conditions

Post Partum Hemorrhage 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

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

faculty of medicine Cairo university

Giza, 11231, Egypt

About this study

A double-blind randomized study conducted on 1200 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (600 women) or combination of 5 IU oxytocin and 0.5 mg ergometrine (600 women) after fetal extraction and before placental removal.

Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All participants are at 37 - 40 weeks of gestational age
  • Noncomplicated pregnancy.
  • obese women with BMI > 30.

Exclusion criteria

  • Participants with placenta previa,
  • coagulopathy,
  • preeclamptic
  • known sensitivity to carbetocin,oxytocin or methergine were excluded

Treatment and study plan

Carbetocin

Drug

single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).

Syntometrine

Drug

one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 microgram of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes

Primary outcomes

  1. incidence of postpartum hemorrhage after CS

    Time frame: 24 hours

    Number of participants experienced massive postpartum hemorrhage

Secondary outcomes

  1. side effects of drugs used

    Time frame: 24 hours

    GIT side effects as nausea , vomiting

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage in Obese Women Undergoing Elective Cesarean Delivery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2018
Registry last updated
Jan 3, 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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