Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section

NCT ID: NCT03148717

Last Updated: 2018-03-22

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-10

Study Completion Date

2018-03-20

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 December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol.

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.

Detailed Description

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Conditions

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Neonatal Outcome

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 rectal 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative rectal placebo"2 tablets".

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Cytotec

Placebo

Intervention Type OTHER

Placebo tablet similar in shape, odour and consistency to misoprostol tablet.

Postoperative

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

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Cytotec

Placebo

Intervention Type OTHER

Placebo tablet similar in shape, odour and consistency to misoprostol tablet.

Interventions

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Misoprostol

Cytotec

Intervention Type DRUG

Placebo

Placebo tablet similar in shape, odour and consistency to misoprostol tablet.

Intervention Type OTHER

Other Intervention Names

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Mesotac

Eligibility Criteria

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Inclusion Criteria

1. Patients candidate for cesarean section.
2. Full term pregnancies (GA 37- 42 Wks).
3. Age (18-40 yrs).
4. body mass index (BMI) (20-30(Kg/m2 .

Exclusion Criteia:

1. Contraindication to spinal anesthesia.
2. Blood dyscrasias.
3. Large fibroids.
4. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
5. Emergency CS such as fetal distress
6. 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

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed S Sweed, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AS1380

Identifier Type: -

Identifier Source: org_study_id

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