Uterotonics for Severe Preeclampsia

Not Applicable

Completed

• Conditions: Preeclampsia Severe
• Interventions: Drug: Carbetocin; Drug: Oxytocin; Drug: Misoprostol

• Registration Number: NCT04756661
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-12-31
• Status Verified: 2021-02
• Study Completion: 2021-02-10
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Last Update Submitted: 2021-02-12
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbetocin	Carbetocin	Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby.
Oxytocin plus misoprostol	Misoprostol	Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.
Oxytocin plus misoprostol	Oxytocin	Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.

Primary Outcome Measures

Name	Time	Method
The rate of postpartum hemorrhage more than 1000 ml	30 minutes	the amount of bleeding during and after CS

Trial Locations

Locations (1)

Assiut Faculty of Medicine; 🇪🇬 Assiut, Egypt