Misoprostol in Termination of First Trimester Missed Abortion

November 24, 2008 updated by: Hawler Medical University

Oral Versus Vaginal Misoprostol as Cervical Ripening Agent Prior to Surgical Termination of First Trimester Missed Abortions in Hawler Maternity Teaching Hospital in Erbil/Iraq

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hawler
      • Erbil, Hawler, Iraq, 964
        • Maternity Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Other Names:
  • PHARMACIA CORPORATION - Istanbul, serial number 022-00
  • 200 microgram a tablet
Experimental: 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
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.
Other Names:
  • PHARMACIA CORPORATION - Istanbul, serial number 022-00
  • 200 microgram a tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Priming with misoprostol administered orally or vaginally three hours before surgical termination of first trimester missed abortion under general anesthesia facilitates cervical dilatation
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Higher patient satisfaction for self administered oral misoprostol at home
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 25, 2008

Last Update Submitted That Met QC Criteria

November 24, 2008

Last Verified

November 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Miscarriage

Clinical Trials on Misoprostol ( Cytotec) 200 microgram a tablet

3
Subscribe