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Misoprostol in Termination of First Trimester Missed Abortion

Primary Purpose

Miscarriage

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Misoprostol ( Cytotec) 200 microgram a tablet
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Miscarriage focused on measuring First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal, first trimester missed abortion

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Maternity Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vaginal Misoprostol

Oral Misoprostol

Arm Description

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

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

Outcomes

Primary Outcome Measures

Priming with misoprostol administered orally or vaginally three hours before surgical termination of first trimester missed abortion under general anesthesia facilitates cervical dilatation

Secondary Outcome Measures

Higher patient satisfaction for self administered oral misoprostol at home

Full Information

First Posted
November 21, 2008
Last Updated
November 24, 2008
Sponsor
Hawler Medical University
Collaborators
HAWLER Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00797693
Brief Title
Misoprostol in Termination of First Trimester Missed Abortion
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hawler Medical University
Collaborators
HAWLER Maternity Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage
Keywords
First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal, first trimester missed abortion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal Misoprostol
Arm Type
Experimental
Arm Description
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
Arm Title
Oral Misoprostol
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Misoprostol ( Cytotec) 200 microgram a tablet
Other Intervention Name(s)
PHARMACIA CORPORATION - Istanbul, serial number 022-00, 200 microgram a tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Higher patient satisfaction for self administered oral misoprostol at home
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Maternity Teaching Hospital
City
Erbil
State/Province
Hawler
ZIP/Postal Code
964
Country
Iraq

12. IPD Sharing Statement

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Misoprostol in Termination of First Trimester Missed Abortion

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