Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

Study Overview
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Brief Summary
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Research objective To compare effectiveness of oral Misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis Effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is not different from placebo Alternative hypothesis: : Oral Misoprostal for cervical priming in Premenopausal women underwent to diagnostic hysteroscopy is better than placebo

Detailed Description
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Research design Randomized double-blinded placebo-controlled trial. The investigators who assess the outcomes and the participants do not know Misoprostal group or control group. The patients are given the random concealed envelop which contains Misoprostal or placebo to take before hysteroscopy. Surgeon and the investigator whom assess patients do not know group allocation.

Official Title
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Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Premenopausal Women Underwent to Diagnostic Hysteroscopy: Double-blind, Randomized Placebo-Controlled Trial

Conditions
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Abnormal Uterine Bleeding, Chronic Pelvic Pain, Infertility, Female

Intervention / Treatment
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* Drug: Misoprostol 200Mcg Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal women Patients have following indication for diagnosis hysteroscopy Abnormal uterine bleeding Unexplained infertility Recurrent pregnancy loss Chronic pelvic pain Late postpartum hemorrhage Patients provided written informed consent Exclusion Criteria: Postmenopausal women Patients who have contraindication for Misoprostal as following Allergic to Misoprostal Medical illnesses such as cardiovascular diseases, Asthma, Renal disease Patients who have contraindication for Hysteroscopoy as following Pregnant women Pelvic inflammatory disease Infection at cervix and vagina Cervical cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostal group<br>Patients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy | Drug: Misoprostol 200Mcg Tab<br>* patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy<br>|
| No Intervention: Placebo group<br>Patients were take placebo 2 tab per oral 3 hour before hysteroscopy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial cervical diameter | The initial hedgar dilator number which can easily insert through cervix | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical priming, Diagnosis hysteroscopy, Oral Misoprostal, Premenopause