NCT02534883

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 12, 2018

Completed
Last Updated

July 12, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

August 25, 2015

Results QC Date

February 1, 2018

Last Update Submit

June 14, 2018

Conditions

Stenosis of Cervix

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of Recorded Side Effects.

    At time of surgery/cervical dilation

  • Dilation Time in Minutes

    At time of procedure.

  • Maximum Dilator Size

    At time of procedure.

  • Number of Complications

    At time of procedure.

  • Resistance Score

    At time of procedure.

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Group 2

PLACEBO COMPARATOR

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

Interventions

MisoprostolDRUG

To be place vaginally

Also known as: Cytotec
Group 1
PlaceboDRUG

To be placed vaginally

Also known as: non active drug
Group 2

Eligibility Criteria

Age45 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Donald Gregory Ward, MD
Organization
St. Louis University
dgreg.ward@health.slu.edu
314-781-1505

Study Officials

  • Donald Ward, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 25, 2015

First Posted

August 28, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 12, 2018

Results First Posted

July 12, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)