Cervical Ripening in Postmenopausal Women

Cervical Ripening in Postmenopausal Women: A Randomized, Double Blind, Placebo Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Stenosis of Cervix
• Intervention / Treatment: Drug: Misoprostol; Drug: Placebo

Detailed Description

This study will be a randomized, double blinded, placebo controlled trial.

Patients will be assigned by chance to receive 200ug of misoprostol or placebo (empty gelatin capsule) vaginally twice (for a total of 400ug). There is no standard of care, but to receive misoprostol or not are both accepted practices and that Standard of Care is for the clinicians to use clinical judgment .

Patients will be randomized to one of the following treatment regimens:

Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). St. Mary's pharmacy will prepare capsules with each containing 200ug of misoprostol.

Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery.

The two groups, will be compared in terms of side effects, resistance, dilation time, size and surgical complication.

Randomization will occur using a computer program called Research Randomizer, http://www.randomizer.org/form.htm. A set of 100 non-unique numbers will be randomized. Once the randomization list is generated, envelopes will be made. Based on the randomizer results a folder slip of paper with the treatment (misoprostol or placebo) written on it will be placed in sequential numbered envelopes. The number on the envelope will be the patients code number. An unblinded member of the research team will open the randomized envelope, and log into a master drug log the randomization.

The medication and/or placebo will be place in numbered sequentially bottles with a master drug log containing which is misoprostol and which is placebo. Each bottle will have child proof lids for dispensing and will be labeled misoprostol 200ug/each/placebo), physician name (Ward) and contact number, and "For investigational use only" will also be noted.

The unblinded staff will notify the research member consenting the patient and inform them of what number bottle to give to the patient, in the office before surgery

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • St. Mary's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 45-80yrs of age
• Postmenopausal (amenorrhea for greater than 1 year)
• May or may not be using hormone replacement therapy
• Scheduled or to be scheduled for hysteroscopy/resectoscopy procedures

Exclusion Criteria:

• Pregnant
• Known Cancer
• Known hypersensitivity to prostaglandins.
• Those who are breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol).	Drug: Misoprostol; To be place vaginally; Other Names: Cytotec
Placebo Comparator: Group 2; Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery.	Drug: Placebo; To be placed vaginally; Other Names: non active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy (Cervical Ripening)	To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation.	At time of surgery/cervical dilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Recorded Side Effects.	Secondary aim: to evaluate if cervical ripening with misoprostol reduces side effects	At time of surgery/cervical dilation
Dilation Time in Minutes	Time from beginning of cervical dilation to completion of cervical dilation.	At time of procedure.
Maximum Dilator Size	The largest cervical dilator that could be passed through the internal cervical os.	At time of procedure.
Number of Complications	Count of complications at time of surgery.	At time of procedure.
Resistance Score	Ease of Dilation Per Surgeon on a numeric scale of 1(easier than normal) to 5 (more difficult than normal) with 3 being "normal."	At time of procedure.

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Donald Ward, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: August 27, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 25065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No