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

Purpose

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	Intervention	Phase
Cervical Preparation	Drug: Mifepristone Device: osmotic dilators	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

Resource links provided by NLM:

Drug Information available for: Mifepristone

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:

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:

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
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
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
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
Cervical Dilation Achieved [ Time Frame: At time of abortion ]
Cervical dilation at start of procedure
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.
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."


Enrollment:	50
Study Start Date:	July 2011
Study Completion Date:	August 2013
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436279

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


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 )
Study First Received:	September 15, 2011
Results First Received:	April 11, 2017
Last Updated:	May 16, 2017
Individual Participant Data
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

ClinicalTrials.gov processed this record on June 23, 2017

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