Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
Primary Purpose
Abnormal Uterine Bleeding, Chronic Pelvic Pain, Infertility, Female
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Misoprostol 200Mcg Tab
Sponsored by
About this trial
This is an interventional treatment trial for Abnormal Uterine Bleeding focused on measuring Cervical priming, Diagnosis hysteroscopy, Oral Misoprostal, Premenopause
Eligibility Criteria
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
Sites / Locations
- Rajavithi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Misoprostal group
Placebo group
Arm Description
Patients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy
Patients were take placebo 2 tab per oral 3 hour before hysteroscopy
Outcomes
Primary Outcome Measures
initial cervical diameter
The initial hedgar dilator number which can easily insert through cervix
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03638856
Brief Title
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
Official Title
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Premenopausal Women Underwent to Diagnostic Hysteroscopy: Double-blind, Randomized Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding, Chronic Pelvic Pain, Infertility, Female
Keywords
Cervical priming, Diagnosis hysteroscopy, Oral Misoprostal, Premenopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Misoprostal group
Arm Type
Experimental
Arm Description
Patients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy
Arm Title
Placebo group
Arm Type
No Intervention
Arm Description
Patients were take placebo 2 tab per oral 3 hour before hysteroscopy
Intervention Type
Drug
Intervention Name(s)
Misoprostol 200Mcg Tab
Intervention Description
patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy
Primary Outcome Measure Information:
Title
initial cervical diameter
Description
The initial hedgar dilator number which can easily insert through cervix
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
need to evaluation of cervical priming
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
We'll reach out to this number within 24 hrs