Misoprostol in Office Hysteroscopy and Endometrial Biopsy
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|ClinicalTrials.gov Identifier: NCT03547778|
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Office Hysteroscopy and Endometrial Biopsy||Drug: Misoprostol 50 mcg pesssary Drug: Placebos||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A Double Blind Randomized Controlled Trial|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||The participants and the care providers (performing the procedure) will not know about the randomization. The research coordinator will perform the randomization and the medicine dispensed by the pharmacy. The study drug and placebo are similar looking, hence the participants and providers would not be able to identify them.|
|Official Title:||Efficacy of Vaginal Misoprostol For Pain Relief During Office Hysteroscopy and Endometrial Biopsy; A Double Blind Randomized Controlled Trial|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Misoprostol group
Patients in this arm will receive vaginal misoprostol (50 mcg), the night before the procedure (concurrent office hsyteroscopy and endometrial biopsy).
Drug: Misoprostol 50 mcg pesssary
Participants in the study arm will receive vaginal misoprostol (50 mcg) to be inserted the night before the procedure. Whereas the control group will get a placebo.
Placebo Comparator: Placebo group
Participants in this group will receive placebo (fatty acid), which looks similar to misoprostol and has to be inserted vaginally the night before the procedure.
The control group will receive placebo pessaries to be inserted vaginally the night before the procedure.
- Pain score recorded in VAS [ Time Frame: Day of procedure ]The current study aims to evaluate if vaginal misoprostol (50 mcg) administered prior to Office hysteroscopy and endometrial biopsy when performed successively in the same office visit decreases overall pain perception during the procedure among subgroup of women who are anticipated to have difficult entry into the cervical canal
- Cervical dilatation [ Time Frame: Day of procedure ]We intend to investigate whether vaginal misoprostol use reduces the need for dilatation and eventually helps in successfully completing the procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547778
|Contact: Anthony Imudia, MDfirstname.lastname@example.org|
|Contact: Papri Sarkar, MDemail@example.com|
|United States, Florida|
|University of South Florida, Department of Obstetrics and Gynecology||Recruiting|
|Tampa, Florida, United States, 33606|
|Contact: Linda Odibo, RN, BSc, MSC firstname.lastname@example.org|