Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

NCT ID: NCT01436279

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-08-31

Brief Summary

In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.

Conditions

Cervical Preparation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mifepristone + misoprostol

Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

Group Type: EXPERIMENTAL

Mifepristone

Intervention Type: DRUG

200 mg po 20-24 hours prior to the procedure

Osmotic dilators

Placed 20-24 hours prior to procedure

Group Type: ACTIVE_COMPARATOR

osmotic dilators

Intervention Type: DEVICE

osmotic dilators placed in the cervix 20-24 hours prior to the procedure

Interventions

Mifepristone

200 mg po 20-24 hours prior to the procedure

Intervention Type: DRUG

osmotic dilators

osmotic dilators placed in the cervix 20-24 hours prior to the procedure

Intervention Type: DEVICE

Other Intervention Names

Mifeprex; RU-486; Mifegyne; Laminaria; Dilapan-S; Dilapan

Eligibility Criteria

Inclusion Criteria

• Women 18-50 years of age undergoing surgical termination of pregnancy
• English or Spanish speaking
• Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
• Eligible for a dilation and evacuation abortion with local anesthesia and sedation
• Ultrasound for dating purposes done within the last two weeks

Exclusion Criteria

• Intrauterine infection
• Fetal demise
• Ruptured membranes
• Multiple gestation
• Uterine anomaly or significant distortion of the uterus with fibroids
• BMI greater than 45
• Inability to place osmotic dilators
• Active substance abuse or intoxication
• Adrenal failure, chronic corticosteroid use, anticoagulant usage
• Severe cervicitis, until treated and resolved
• Prior Cesarean section

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarita Sonalkar, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston University

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

AU 6003109

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-31032

Identifier Type: -

Identifier Source: org_study_id