MedTrace Logo

Cervical Ripening in Postmenopausal Women

NCT02534883 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-07-12

Study results available
· View outcomes & findings →

Summary

Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix for dilation (opening). This is to assist with the insertion of a hysteroscope (the surgical instrument) into the uterus for all operative hysteroscopic procedures requiring dilation above 5 mm.

Time required for cervical dilatation will be recorded. Start time will be when the smallest dilator is placed into the endocervical canal, and stop time recorded when the desired cervical dilation is achieved with the largest dilator. Depending on the procedure, desired dilation may range between 5-10mm. Time will serve as a surrogate for operative ease of dilatation.

The investigators will compare the two groups in terms of medication, resistance, dilation time and size, side effects and surgical complications.

Conditions

  • Stenosis of Cervix

Interventions

DRUG

Misoprostol

To be place vaginally

DRUG

Placebo

To be placed vaginally

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Donald Ward, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02534883 on ClinicalTrials.gov