CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 192 enrolled
Drug / intervention
Misoprostoldrug
Likely dose
Misoprostol 400 microgramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06364098
NCT06364098Phase 1Completed

Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections: A Randomized Controlled Trial

Cairo University·interventional·Posted Apr 15, 2024·Updated Apr 15, 2024

In Brief

A Phase 1 clinical trial evaluating Misoprostol for Postpartum Hemorrhage. Completed, enrolled 192 participants across 1 site.

Detailed Summary

Study design: A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University. Population of study: 192 pregnant women at the age range from 20 to 35 years, with BMI \< 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age \>39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan) and candidate for elective cesarean delivery (Previous one or two cesarean section) were included in our study. Patients with uterine over distension as due to multiple pregnancies or polyhydramnios, multipara (parity ≥3), women with uterine fibroids, antepartum hemorrhage presentation such as placenta previa, placental abruption or vasa previa, moderate to severe anemia with hemoglobin level \<9mg/dl, patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias, hypertension, cardiovascular, DM, hepatic, or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone, antacids containing magnesium were excluded from our study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedApr 15, 2024
Enrollment StartJan 1, 2022
Primary CompletionFeb 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.2 years ago

Interventions

Misoprostoldrug

400 microgram of misoprostol given either sublingually or intrauterine during CS after placental removal together with IV oxytocin infusion