Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks

NCT01636063 | Terminated Results DMC

• 1 other identifier: SFPRF12-16
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical abortion in the late first trimester and early second trimester is usually performed with the aid of a cervical preparing agent, which helps to open up the uterine cervix for the procedure. Routine use of cervical preparants is recommended by several organizations during this period of pregnancy before surgical abortion, especially in younger women or those who have not delivered a baby, because their cervices may be more difficult to dilate without a preparant. The standard medication used for cervical preparation is misoprostol. Unfortunately, misoprostol may cause uncomfortable uterine cramping and vaginal bleeding in patients who use it. Another medication called mifepristone has been shown to dilate the cervix better than misoprostol in the first trimester, but little information exists about using mifepristone in the late first trimester and early second trimester. The investigators plan to perform a prospective, double-blind, randomized trial to evaluate if mifepristone is a better cervical preparant than misoprostol. A total of 110 participants who are pregnant women desiring pregnancy termination 11 to 15 weeks gestational age will be recruited. Half will receive mifepristone and the other half misoprostol. The investigators will measure the amount of cervical dilation achieved right before a surgical abortion to determine if mifepristone is significantly different than misoprostol as a cervical preparant at this stage of pregnancy. The investigators expect that mifepristone will work better than misoprostol for this purpose. The investigators hope to generate information about mifepristone so that women and their health care providers can know more about mifepristone as an option for cervical preparation before surgical abortion.

Conditions

Induced Abortion; Abortion Techniques; Mifepristone; Misoprostol

Keywords

Induced Abortion; Abortion Techniques; Mifepristone; Misoprostol; Initial Cervical Dilation

Outcome Measures

Primary Outcomes (1)

• Initial Cervical Dilation at the Time of Surgical Abortion

  Initial cervical dilation as measured in French units by a Pratt cervical dilator prior to surgical abortion. The dilation was measured in French units with each French unit being equivalent to 0.33 mm.

  24 to 48 hours after enrollment

Study Arms (2)

Mifepristone

EXPERIMENTAL

Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion

Drug: Mifepristone

Misoprostol

ACTIVE COMPARATOR

Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.

Drug: Misoprostol

Interventions

Mifepristone DRUG

Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure

Also known as: RU-486

Mifepristone

Misoprostol DRUG

Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure

Also known as: Cytotec

Misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater or equal to 18 years
• Fluency in English or Spanish
• Intrauterine pregnancy between 11 0/7 and 15 0/7 on the day of the abortion procedure
• Desire for pregnancy termination
• Ability to return for abortion procedure 24-48 hours after the preoperative visit

You may not qualify if:

• Allergy or contraindication to study agents
• Requirement of general anesthesia to perform the abortion
• Diagnosis of missed abortion, spontaneous abortion, incomplete abortion, or threatened abortion at time of initial preoperative evaluation

Sponsors & Collaborators

• Boston University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: David R Kattan
• Organization: Baystate Medical Center

davidrkattan@gmail.com

413-794-5256

Study Officials

• Primary Investigator

  Boston 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: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 10, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 22, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)