Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

Stanford University

Status: Withdrawn

Conditions: Legally Induced Abortion Without Mention of Complication

Treatments: Drug: Misoprostol; Device: Hygroscopic cervical dilators; Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT02679092

IRB-36302

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Dilapan (14wks 0days-15wks, 6days)

Active Comparator group

Description:

The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure.

Treatment:

Device: Hygroscopic cervical dilators

Dilapan (16wks 0days-18wks, 6days)

Active Comparator group

Description:

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.

Treatment:

Device: Hygroscopic cervical dilators

Drug: Misoprostol

Mifepristone (14wks 0days-15wks, 6days)

Experimental group

Description:

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.

Treatment:

Drug: Mifepristone

Drug: Misoprostol

Mifepristone (16wks 0days-18wks, 6days)

Experimental group

Description:

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.

Treatment:

Drug: Mifepristone

Drug: Misoprostol