Cervical Ripening in Postmenopausal Women

Stopped early · Not applicable · Has a placebo group

Conditions studied: Stenosis of Cervix

In brief

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.

Key facts

Study ID

NCT02534883

Run by

St. Louis University

People needed

11

Starts

2015-08-01

Expected to finish

2016-12-01

Last updated by the study team

2018-07-12

Who can join

Age: 45 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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