Misoprostol in Termination of First Trimester Missed Abortion

Not Applicable

Completed

• Conditions: Miscarriage
• Interventions: Drug: Misoprostol ( Cytotec) 200 microgram a tablet

• Registration Number: NCT00797693
• Lead Sponsor: Hawler Medical University

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-11
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-24
• Last Update Submitted: 2008-11-24
• Study First Posted: 2008-11-25
• Last Update Posted: 2008-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Misoprostol	Misoprostol ( Cytotec) 200 microgram a tablet	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
Oral Misoprostol	Misoprostol ( Cytotec) 200 microgram a tablet	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Higher patient satisfaction for self administered oral misoprostol at home	6 months

Trial Locations

Locations (1)

Maternity Teaching Hospital; 🇮🇶 Erbil, Hawler, Iraq