Uterotonics for Severe Preeclampsia

Overview

The study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia

Full Title of Study: “Carbetocin Versus Combined Oxytocin and Misoprostol for Prevention of Postpartum Hemorrhage in Women With Severe Preeclampsia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Drug: Carbetocin
    • 100 mcg of Carbetocin intravenous injection
  • Drug: Oxytocin
    • 10 IU oxytocin IV drip
  • Drug: Misoprostol
    • 400 mcg rectal

Arms, Groups and Cohorts

  • Experimental: Carbetocin
    • Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby.
  • Active Comparator: Oxytocin plus misoprostol
    • Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.

Clinical Trial Outcome Measures

Primary Measures

  • The rate of postpartum hemorrhage more than 1000 ml
    • Time Frame: 30 minutes
    • the amount of bleeding during and after CS

Participating in This Clinical Trial

Inclusion Criteria

  • Pregnant women which diagnosed with severe pre-eclampsia. – Singleton pregnancy. – Termination of pregnancy by Cesarean section after 28 weeks of gestation. Exclusion Criteria:

  • Suspected or proven placental abruption. – Known placenta Previa or acreata. – Multiple pregnancies. – Obesity (BMI >35). – Anemia (<9 g/dl). – Retained placental tissues. – Big baby (> 4 kg). – Presence of coagulopathy. – Polyhydramnios. – Presence of Uterine fibroids. – Medical diseases as; cardiac, liver, renal or endocrine diseases. – General anesthesia.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Mohamed Abbas, Principal investigator – Assiut University

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