Misoprostol in Termination of First Trimester Missed Abortion

Miscarriage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797693
• Other study ID #: 324/2
• Status: Completed
• Phase: N/A
• First received: November 21, 2008
• Last updated: November 24, 2008
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: November 2008
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: IRAQ: HAWLER COLLEGE OF MEDICINE
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Missed
• Miscarriage

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Iraq	Maternity Teaching Hospital	Erbil	Hawler

Sponsors (2)

Lead Sponsor	Collaborator
Hawler Medical University	HAWLER Maternity Hospital

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Higher patient satisfaction for self administered oral misoprostol at home		6 months	Yes