Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks (SaMi2)

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.

Study Overview

• Status: Completed
• Conditions: Cervical Preparation
• Intervention / Treatment: Drug: Mifepristone; Device: osmotic dilators

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mifepristone + misoprostol; Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure	Drug: Mifepristone; 200 mg po 20-24 hours prior to the procedure; Other Names: RU-486; Mifeprex; Mifegyne
Active Comparator: Osmotic dilators; Placed 20-24 hours prior to procedure	Device: osmotic dilators; osmotic dilators placed in the cervix 20-24 hours prior to the procedure; Other Names: Laminaria; Dilapan-S; Dilapan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	Interval from initiation of vacuum aspiration 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.
Subject Discomfort Before the Abortion	Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe	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	Amount of pain medication used during the procedure: reported as micrograms of fentanyl	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	Amount of pain medication used during the procedure: reported as milligrams of midazolam	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	Cervical dilation at start of procedure	At time of abortion
Acceptability to Patient	Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was "yes" is being reported.	After procedure completion
Difficulty of Procedure	Outcome measure is the number and percentage of participants where the provider rated the procedure as "difficult or very difficult". Provider assessment of difficulty of procedure categories were: "very easy", "easy", "moderate", "difficult", or "very difficult."	After completion of procedure

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Sarita Sonalkar, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: September 16, 2011
• First Posted (Estimate): September 19, 2011

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone
• Other Study ID Numbers: H-31032; AU 6003109 (Other Grant/Funding Number: Society of Family Planning)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No