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OpenTrials
Completed

NCT Number: NCT02044549

Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

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

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Key information

Conditions

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

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Maged

Cairo, 12151, Egypt

About this study

A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 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.

Exclusion criteria

  • Participants with placenta previa
  • Patients with coagulopathy
  • preeclamptic women
  • known sensitivity to oxytocin or methergine were excluded

Treatment and study plan

Carbetocin

Drug

Oxycontin analogue

Other names: Pabal

Syntometrine

Drug

Uterotonins

Other names: Oxytocin methergine combination

Primary outcomes

  1. prevention of post partum hemorrhage after CS

    Time frame: 24 hours

    Number of participants experienced postpartum hemorrhage

Secondary outcomes

  1. side effects of drugs used

    Time frame: 24 hours

    Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 24, 2014
Registry last updated
Jun 24, 2021

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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