Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.

Official Title
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Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil

Conditions
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Missed Abortion

Intervention / Treatment
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* Drug: Misoprostol (given buccally)
* Drug: Misoprostol (given vaginally)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first trimester missed abortion Exclusion Criteria: history or evidence of disorders that represent contraindication to the use of misoprostol: severe pulmonary diseases congenital or acquired heart diseases glaucoma prolonged use of corticosteroid sickle cell anemia and adrenal insufficiency smokers known hypersensitivity to drugs any evidence of infection patient's refusal to participate in the study patients with abnormal results of investigations patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage patients with complete abortion patients with severe bleeding that required emergency surgical evacuation of the uterus patients with partially dissolved tablets at the site of application in both groups

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Buccal Misoprostol<br>Group one: 50 patients with first trimester missed abortion received buccal misoprostol | Drug: Misoprostol (given buccally)<br>* 400 microgram misoprostol given buccally three hours before dilation and curettage (PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)<br>* Other names: serial number 022-00;|
| Active Comparator: Vaginal Misoprostol<br>Group two: 5 patients received vaginal misoprostol | Drug: Misoprostol (given vaginally)<br>* 400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)<br>* Other names: serial number 022-00;|
| Active Comparator: Buccal and Vaginal Misoprostol<br>50 primiparous and 50 multiparous women: one hundred patients have been administered the medication buccally (25 primigravida and 25 multigravida), and vaginally (25 primigravida and 25 multigravida), three hours before dilation and curettage. They were admitted to the hospital one day before the surgical evacuation, and preparation of cross matched blood done for all recruited subjects. Each group was randomly allocated (1,3,5,... for the buccal group & 2,4,6,... for the vaginal group) to receive 400 microgram misoprostol. | Drug: Misoprostol (given buccally)<br>* 400 microgram misoprostol given buccally three hours before dilation and curettage (PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)<br>* Other names: serial number 022-00;Drug: Misoprostol (given vaginally)<br>* 400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)<br>* Other names: serial number 022-00;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.) |  | March 2007 to March 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objectives are to compare the side effects and acceptability by the subjects. |  | March 2007 to March 2008 | 

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