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Misoprostol in Termination of First Trimester Missed Abortion

NCT ID: NCT00797693

Last Updated: 2008-11-25

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to determine whether oral versus vaginal misoprostol is effective in termination of first trimester missed abortion and to compare between two different routes.

Detailed Description

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Objective: To compare the effectiveness of oral versus vaginal misoprostol prior to surgical termination of first trimester missed abortion as cervical priming agent , the difference of cervical dilatation immediately prior to operation , the duration of operation and side effects between two treatment groups.

Design: This study was conducted as randomised study.

Setting: Maternity Teaching Hospital in Hawler/ Kurdistan/ Iraq.

Population: Over a period of six months from the first of January to the thirtieth of June, 2008, one hundred women were included in this study. They were cases of first trimester abortion (6-12 weeks).

Method: Patients were randomly selected for the type of treatment they received. The first group (oral) were assigned to receive 400 micrograms of misoprostol orally as preoperative cervical priming agent, where as the second group (vaginal) were allocated to have treatment either with vaginal misoprostol to receive 400 micrograms vaginally.

Main outcome measure: Oral versus vaginal misoprostol as cervical ripening agent prior to termination of first trimester missed abortion.

Keywords: First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal.

Conditions

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Miscarriage

Keywords

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First trimester missed abortion misoprostol cervical ripening oral vaginal first trimester missed abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vaginal Misoprostol

A drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix

Group Type EXPERIMENTAL

Misoprostol ( Cytotec) 200 microgram a tablet

Intervention Type DRUG

In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.

Oral Misoprostol

A drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix

Group Type EXPERIMENTAL

Misoprostol ( Cytotec) 200 microgram a tablet

Intervention Type DRUG

In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.

Interventions

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Misoprostol ( Cytotec) 200 microgram a tablet

In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.

Intervention Type DRUG

Other Intervention Names

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PHARMACIA CORPORATION - Istanbul, serial number 022-00 200 microgram a tablet

Eligibility Criteria

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Inclusion Criteria

* All patients were cases of first trimester missed abortion.
* They have uneventful history apart from history of slight vaginal bleeding, with normal general examination. Gynecological examination revealed no vaginal bleeding or discharge with no dilatation of the internal os with enlarged uterus.

Exclusion Criteria

* Cases with suspected or proven ectopic pregnancy, history of Caesarean section, medical diseases, a known hypersensitivity to a drug, smokers, patients with abnormal results of investigation and the presence of vaginal bleeding were excluded from the study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HAWLER Maternity Hospital

UNKNOWN

Sponsor Role collaborator

Hawler Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hawler Medical University

Locations

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Maternity Teaching Hospital

Erbil, Erbil, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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324/2

Identifier Type: -

Identifier Source: org_study_id