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

Phase 3

Completed

Conditions: Cervical Preparation

Interventions: Device: osmotic dilators
Drug: Mifepristone

Registration Number: NCT01436279

Lead Sponsor: Boston University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 50

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osmotic dilators	osmotic dilators	Placed 20-24 hours prior to procedure
Mifepristone + misoprostol	Mifepristone	Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

Primary Outcome Measures

Name	Time	Method
Length of Procedure	Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.	Interval from speculum insertion to speculum removal

Secondary Outcome Measures

Name	Time	Method
Cervical Dilation Achieved	At time of abortion	Cervical dilation at start of procedure
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 was subjectively described by the subjects as : None, Mild, Moderate, Severe
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.	Amount of pain medication used during the procedure: reported as micrograms of fentanyl
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.	Interval from initiation of vacuum aspiration to speculum removal
Acceptability to Patient	After procedure completion	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.
Difficulty of Procedure	After completion 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."
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.	Amount of pain medication used during the procedure: reported as milligrams of midazolam