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NCT03638856 Clinical Trial

Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03638856
Other study ID # Rjcyto2531
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2018
Est. completion date December 30, 2018

Study information
Verified date June 2018
Source Rajavithi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Premenopausal women 2. Patients have following indication for diagnosis hysteroscopy - Abnormal uterine bleeding - Unexplained infertility - Recurrent pregnancy loss - Chronic pelvic pain - Late postpartum hemorrhage 3. Patients provided written informed consent Exclusion Criteria: 1. Postmenopausal women 2. Patients who have contraindication for Misoprostal as following - Allergic to Misoprostal - Medical illnesses such as cardiovascular diseases, Asthma, Renal disease 3. Patients who have contraindication for Hysteroscopoy as following - Pregnant women - Pelvic inflammatory disease - Infection at cervix and vagina - Cervical cancer

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Misoprostol 200Mcg Tab
patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy

Locations
Country Name City State
Thailand Rajavithi Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary initial cervical diameter The initial hedgar dilator number which can easily insert through cervix 1 year
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