Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery

NCT ID: NCT03148574

Last Updated: 2021-04-23

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

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-02

Study Completion Date

2019-12-15

Brief Summary

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Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy

Detailed Description

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Conditions

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Post Partum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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misoprostol

intrauterine 400 microgram

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

intrauterine tablets

oxytocin

intravenous infusion 10 units

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

intravenous

Interventions

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Misoprostol

intrauterine tablets

Intervention Type DRUG

Oxytocin

intravenous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins.

3-Had no history of coagulopathy. 4-Accepting to participate in the study.

Exclusion Criteria

\\1-women with anemia (Haemoglobin \<8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy
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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Assiut Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IUM

Identifier Type: -

Identifier Source: org_study_id

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