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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Cervical Preparation	Drug: Mifepristone; Device: osmotic dilators	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
Study Start Date :	July 2011
Actual Primary Completion Date :	August 2013
Actual Study Completion Date :	August 2013

Arms and Interventions

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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: Mifeprex; RU-486; 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

Outcome Measures

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Primary Outcome Measures :

1. Length of Procedure [ Time Frame: 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 :

1. Operative Time [ Time Frame: 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
2. Subject Discomfort Before the Abortion [ Time Frame: 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
3. Pain Medication (Fentanyl) During the Abortion [ Time Frame: 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
4. Pain Medication (Midazolam) During the Abortion [ Time Frame: 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
5. Cervical Dilation Achieved [ Time Frame: At time of abortion ]
   Cervical dilation at start of procedure
6. Acceptability to Patient [ Time Frame: 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.
7. Difficulty of Procedure [ Time Frame: 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."

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Boston University

Society of Family Planning

Investigators

Principal Investigator:	Sarita Sonalkar, MD	Boston Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Boston University
ClinicalTrials.gov Identifier:	NCT01436279 History of Changes
Other Study ID Numbers:	H-31032; AU 6003109 ( Other Grant/Funding Number: Society of Family Planning )
First Posted:	September 19, 2011
Results First Posted:	June 14, 2017
Last Update Posted:	June 14, 2017
Last Verified:	May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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

Additional relevant MeSH terms:

Mifepristone; Abortifacient Agents, Steroidal; Abortifacient Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptives, Oral, Synthetic; Contraceptives, Oral; Contraceptive Agents, Female	Contraceptive Agents; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Luteolytic Agents; Menstruation-Inducing Agents