Misoprostol in Office Hysteroscopy and Endometrial Biopsy

NCT03547778 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Pro00034137
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Office Hysteroscopy and Endometrial Biopsy

Outcome Measures

Primary Outcomes (1)

• Pain score recorded in VAS

  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

  Day of procedure

Secondary Outcomes (1)

• Cervical dilatation

  Day of procedure

Study Arms (2)

Misoprostol group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Misoprostol 50 mcg pesssary DRUG

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.

Misoprostol group

Placebos DRUG

The control group will receive placebo pessaries to be inserted vaginally the night before the procedure.

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida, Department of Obstetrics and Gynecology

Tampa, Florida, 33606, United States

Location

Related Publications (2)

• Cicinelli E, Didonna T, Ambrosi G, Schonauer LM, Fiore G, Matteo MG. Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: a randomised placebo-controlled double-blind study. Br J Obstet Gynaecol. 1997 Mar;104(3):316-9. doi: 10.1111/j.1471-0528.1997.tb11460.x.

  PMID: 9091008 BACKGROUND

• Urman RD, Punwani N, Bombaugh M, Shapiro FE. Safety considerations for office-based obstetric and gynecologic procedures. Rev Obstet Gynecol. 2013;6(1):e8-e14.

  PMID: 23687556 BACKGROUND

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Double Blind Randomized Controlled Trial

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 6, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 25, 2020
• Last Updated: June 18, 2021

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)