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Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination

NCT ID: NCT01508143

Last Updated: 2012-10-02

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

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

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The aim of this study is to compare two misoprostol regimen in pregnancy termination.

Detailed Description

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Studies on determining the optimal dosage for misoprostol in pregnancy termination are continuing and still there is no evidence for ideal misoprostol regimen for pregnancy termination. The aim of this study is to compare two misoprostol regimen in pregnancy termination.

Conditions

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Termination

Keywords

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Abortion Pregnancy Termination Misoprostol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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400 microgram misoprostol

400 micrograms misoprostol each 6 hours for 8 dose

Group Type EXPERIMENTAL

Misoprostol 400 micrograms

Intervention Type DRUG

Misoprostol 400 micrograms each 6 hours for 8 dose

800 micrograms misoprostol

800 micrograms misoprostol each 12 hours for 4 dose

Group Type ACTIVE_COMPARATOR

Misoprostol 800 micrograms

Intervention Type DRUG

Misoprostol 800 micrograms each 12 hours for 4 doses

Interventions

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Misoprostol 400 micrograms

Misoprostol 400 micrograms each 6 hours for 8 dose

Intervention Type DRUG

Misoprostol 800 micrograms

Misoprostol 800 micrograms each 12 hours for 4 doses

Intervention Type DRUG

Other Intervention Names

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Cytotec Cytotec

Eligibility Criteria

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Inclusion Criteria

* All women who were candidates for early pregnancy termination because of fetal death or other medical conditions
* Before 14th week of gestation calculated according LMP or first trimester sonography

Exclusion Criteria

* Chorioamnionitis
* Hypersensitivity to prosstaglandins
* Past medical history of cardiovascular, kidney or liver or lung diseases
* Positive history for uterus pathologies
* suspicious to extra-uterus pregnancy
* sign and symptoms of uterus infection
* Molar pregnancy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Mahboobi

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

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Iran

Other Identifiers

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Misoprostol in termination

Identifier Type: -

Identifier Source: org_study_id