Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section

NCT ID: NCT03591913

Last Updated: 2018-09-18

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

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-09-01

Brief Summary

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Cesarean section is one of the most common major surgical operations among women. In 2015, the incidence of cesarean section in Woman Health Hospital in Assiut University accounts for 51.3 % of all deliveries

Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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study group

will receive sublingual misoprostol immediately after urinary catheterization and before skin incision

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

Oral tablets

control group

will receive sublingual misoprostol immediately after skin closure

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Oral tablets

Interventions

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Misoprostol

Oral tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All pregnant women who will undergo elective lower segment cesarean section
* term ( ≥ 37 weeks)
* normal fetal heart tracing.

Exclusion Criteria

* Placenta previa-Rupture uterus
* Classical cesarean section
* Preterm delivery
* Hypertensive disorders of pregnancy
* Bleeding tendency
* Previous history of postpartum hemorrhage
* Concurrent anticoagulant therapy
* Concurrent long-term use of steroids
* Fetal distress
* Antepartum haemorrhage
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MISOCS

Identifier Type: -

Identifier Source: org_study_id

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