Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2018-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Preoperative

• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets".

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

mesotac

Placebo

Intervention Type OTHER

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

Postoperative

• Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 400 microgram of misoprostol (Sigma) " 2 tablets" .

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

mesotac

Placebo

Intervention Type OTHER

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

Interventions

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Misoprostol

mesotac

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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 ).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No