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Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss

NCT ID: NCT02083107

Last Updated: 2015-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

636 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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The aim of the work is to evaluate \& compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.

Detailed Description

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Conditions

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Postpartum Hemorrhage

Keywords

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Postpartum hemorrhage Intrapartum blood loss Misoprostol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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sublingual misoprostol & rectal placebo

will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

Comparison of different routes of administration of 400 micro gram misoprostol

rectal & sublingual placebo

will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

rectal misoprostol & sublingual placebo

will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

Comparison of different routes of administration of 400 micro gram misoprostol

Interventions

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Misoprostol

Comparison of different routes of administration of 400 micro gram misoprostol

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Misotac Cytotec

Eligibility Criteria

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Inclusion Criteria

1. Patients booked for elective cesarean section.
2. Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section

Exclusion Criteria

1. Primigravida.
2. Blood dyscrasias.
3. Large fibroids.
4. Multiple pregnancies.
5. Overdistended uterus eg. Hydramnios.
6. Pre-eclampsia.
7. Marked maternal anemia (Preoperative hemoglobin \< 9 gm/dl).
8. Previous history of PPH.
9. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
10. Placenta previa.
11. Contraindication to spinal anesthesia.
12. Previous myomectomy.
13. Previous two or more C.S.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed S Sweed, MD

Mohamed S. Sweed, Lecturer of Obstetrics &Gynecology, Ain Shams University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed S. Sweed, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Mourad M. El-Said, Professor

Role: STUDY_DIRECTOR

AinShams University

Amgad E. Abou-Gamrah, Ass.Prof.

Role: STUDY_DIRECTOR

AinShams university

Haitham El-Sabe, MD

Role: STUDY_DIRECTOR

AinShams University

Mohamed M. AbdEl-Hamid, Registrar

Role: PRINCIPAL_INVESTIGATOR

AinShams University

Locations

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Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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9021344

Identifier Type: -

Identifier Source: org_study_id