Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section

Ain Shams University240 enrolled

Overview

This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till October 2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

240

Conditions

Cesarean Section

Interventions

MisoprostolDRUG

mesotac

PlaceboOTHER

Placebo tablet identical to the misoprostol tablet but without the active ingredient

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients booked for elective cesarean section. * Singleton pregnancies. * Full term pregnancies (GA 37- 42 Wks). * Age (18-40 yrs). * body mass index (BMI) (20-30(Kg/m2 . Exclusion Criteria: * Contraindication to spinal anesthesia. * Blood dyscrasias. * Large fibroids. * Multiple pregnancies. * Overdistended uterus eg. Hydramnios. * Pre-eclampsia. * Marked maternal anemia (Preoperative hemoglobin \< 9 gm/dl). * Previous history of PPH. * Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol. * Placenta previa. * Previous myomectomy. * Extreme of BMI (\<20 or \>30 Kg/m2 ).

Locations (1)

Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

Need for extra uterotonics

Time frame: 24 hours

Secondary Outcomes

intraoperative blood loss

Time frame: intraoperative

postpartum hemorrhage

Time frame: 24 hours

neonatal outcome

measured by APGAR score at 1 and 5 minutes

Time frame: 5 minutes

Data from ClinicalTrials.gov

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