Misoprostol in Termination of First Trimester Missed Abortion

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Miscarriage

Intervention / Treatment
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* Drug: Misoprostol ( Cytotec) 200 microgram a tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Misoprostol<br>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<br>* 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.<br>* Other names: 200 microgram a tablet;|
| Experimental: Oral Misoprostol<br>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<br>* 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.<br>* Other names: 200 microgram a tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal, first trimester missed abortion