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NCT04756661 Clinical Trial

Uterotonics for Severe Preeclampsia

Preeclampsia Severe Clinical Trial

Official title:
Carbetocin Versus Combined Oxytocin and Misoprostol for Prevention of Postpartum Hemorrhage in Women With Severe Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04756661
Other study ID # CARBOXMISO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date February 10, 2021

Study information
Verified date February 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date February 10, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary The rate of postpartum hemorrhage more than 1000 ml the amount of bleeding during and after CS 30 minutes
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