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

NCT01436279 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: H-31032AU 6003109
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Length of Procedure

  Interval from speculum insertion to speculum removal

  Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.

Secondary Outcomes (7)

• Operative Time

  Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

• Subject Discomfort Before the Abortion

  Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

• Pain Medication (Fentanyl) During the Abortion

  Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

• Pain Medication (Midazolam) During the Abortion

  Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

• Cervical Dilation Achieved

  At time of abortion

Study Arms (2)

Mifepristone + misoprostol

EXPERIMENTAL

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

Drug: Mifepristone

Osmotic dilators

ACTIVE COMPARATOR

Placed 20-24 hours prior to procedure

Device: osmotic dilators

Interventions

Mifepristone DRUG

200 mg po 20-24 hours prior to the procedure

Also known as: Mifeprex, RU-486, Mifegyne

Mifepristone + misoprostol

osmotic dilators DEVICE

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

Also known as: Laminaria, Dilapan-S, Dilapan

Osmotic dilators

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Boston University

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Olivera Vragovic
• Organization: Boston Medical Center

Olivera.Vragovic@bmc.org

617 414 7304

Study Officials

• Sarita Sonalkar, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 19, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)