Misoprostol in Termination of First Trimester Missed Abortion - Full Text View

Sponsors and Collaborators:	Hawler Medical University HAWLER Maternity Hospital
Information provided by:	Hawler Medical University
ClinicalTrials.gov Identifier:	NCT00797693

Purpose

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.

Condition	Intervention
Miscarriage	Drug: Misoprostol ( Cytotec) 200 microgram a tablet

MedlinePlus related topics: Pregnancy Loss

Drug Information available for: Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Hawler Medical University:

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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Higher patient satisfaction for self administered oral misoprostol at home [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	January 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vaginal Misoprostol: Experimental 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	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.
Oral Misoprostol: Experimental 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	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.

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.

Eligibility

Ages Eligible for Study:	20 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797693

Locations

Iraq, Hawler
Maternity Teaching Hospital
erbil, Hawler, Iraq, 964

Sponsors and Collaborators

Hawler Medical University

HAWLER Maternity Hospital

More Information

Responsible Party:	Hawler Medical University ( Scientific Committe )
Study ID Numbers:	324/2
Study First Received:	November 21, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797693
Health Authority:	IRAQ: HAWLER COLLEGE OF MEDICINE

Keywords provided by Hawler Medical University:

First trimester
missed abortion
misoprostol
cervical ripening

oral
vaginal
first trimester missed abortion

Study placed in the following topic categories:

Pregnancy Complications
Abortion, Missed
Misoprostol
Abortion, Spontaneous

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Physiological Effects of Drugs
Abortifacient Agents

Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009