Overview

This trial is active, not recruiting.

Condition legally induced abortion without mention of complication
Treatments misoprostol, mifepristone, hygroscopic cervical dilators
Sponsor Stanford University
Start date April 2016
End date February 2018
Trial size 100 participants
Trial identifier NCT02679092, IRB-36302

Summary

Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D&E.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure.
hygroscopic cervical dilators Dilapan-S
osmotic cervical dilators inserted through the internal os
(Active Comparator)
The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
misoprostol Cytotec
400 mcg buccal 60-90 minutes prior to procedure
hygroscopic cervical dilators Dilapan-S
osmotic cervical dilators inserted through the internal os
(Experimental)
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
misoprostol Cytotec
400 mcg buccal 60-90 minutes prior to procedure
mifepristone Danco
200 mg PO on the day prior to D&E
(Experimental)
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
misoprostol Cytotec
400 mcg buccal 60-90 minutes prior to procedure
mifepristone Danco
200 mg PO on the day prior to D&E

Primary Outcomes

Measure
Procedure Time
time frame: Intraoperative

Secondary Outcomes

Measure
Cervical Dilation
time frame: Baseline
Total Procedure Time
time frame: Measured at clinic visit and on OR day, over 2 day period
Difficulty of Procedure, as reported by clinician
time frame: Measured within 5 minutes after procedure
Complications/Adverse Events
time frame: Intraoperatively
Pain Perceived by Patient
time frame: Intraoperatively "Measured during dilator placement"
Overall Patient Experience
time frame: Measured post-operatively (30 minutes prior to discharge)

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - >18 Years Old - Viable, Singleton pregnancy - Voluntarily seeking abortion between 14-19 weeks gestation - Able to give informed consent and comply with study protocol - Fluent in English or Spanish Exclusion Criteria: - Allergy to study drugs

Additional Information

Official title Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
Principal investigator Principal Investigator
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Stanford University.