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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
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
We hypothesize that use of vaginal misoprostol will help in reducing the pain scores when used prior to concurrent office hysteroscopy and endometrial biopsy in a particular subgroup of women who are anticipated to require cervical dilatation.

Condition or disease Intervention/treatment Phase
Office Hysteroscopy and Endometrial Biopsy Drug: Misoprostol 50 mcg pesssary Drug: Placebos Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
Drug Information available for: Misoprostol

Arm Intervention/treatment
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.
Drug: Placebos
The control group will receive placebo pessaries to be inserted vaginally the night before the procedure.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All consecutive female patients aged 18-70 years presenting to the Center for successive OH and EMB with the ability to provide written informed consent and meets at least one of the criteria mentioned below:

  • Previous cesarean section
  • Nulliparous
  • Postmenopausal
  • Previous loop electrosurgical excision procedure (LEEP) or cone biopsy
  • Previous myomectomy

Exclusion Criteria:

Premenopausal multiparous women with no prior surgeries performed on the uterus.

  • Patients unable to provide informed consent
  • Patients visiting the fibroid and endometriosis center with abnormal uterine bleeding, infertility or for preoperative evaluation; however, OH and EMB is not required for their evaluation based on their providers' clinical judgment.
  • Patients with genital tract lesions.

Information from the National Library of Medicine

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


Contacts
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Contact: Anthony Imudia, MD 2489188592 aimudia@health.usf.edu
Contact: Papri Sarkar, MD 8134098335 paprisarkar2@gmail.com

Locations
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United States, Florida
University of South Florida, Department of Obstetrics and Gynecology Recruiting
Tampa, Florida, United States, 33606
Contact: Linda Odibo, RN, BSc, MSC       lodibo@health.usf.edu   
Sponsors and Collaborators
University of South Florida

Publications:
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03547778    
Other Study ID Numbers: Pro00034137
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics