Mifepristone vs Misoprostol
Mifepristone Versus Misoprostol for Cervical Preparation Prior to Procedural Abortion at 12 to 16 Weeks' Gestation in an Academic Medical Center: a Randomized Controlled Pilot Trial
1 other identifier
interventional
94
1 country
1
Brief Summary
The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2024
CompletedFirst Posted
Study publicly available on registry
July 16, 2024
CompletedStudy Start
First participant enrolled
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
August 13, 2025
August 1, 2025
1.9 years
July 9, 2024
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants achieving Intended dilation
The proportion of participants achieving intended dilation at the start of the procedure will be summarized by treatment group and reported in percentages. Achievement of intended dilation will be determined by the attending surgeon. Overdilation resulting in passage of products of conception prior to time of surgery will be characterized as a treatment failure.
At time of surgery
Secondary Outcomes (6)
Cervical dilation at start of procedure
Start of the Procedure
Surgical time
Start to end of procedure, up to 4 hours
Estimated blood loss
Start to end of procedure, up to 4 hours
Presence of Intraoperative Complications
From preoperative visit to discharge, up to 2 days
Patient Satisfaction
From preoperative visit to discharge, up to 2 days
- +1 more secondary outcomes
Study Arms (2)
Mifepristone
EXPERIMENTALPatients will be randomized to Mifepristone-alone in a 1:1 manner prior to procedural abortions. A paracervical block of 20 cubic centimeters (cc) 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.
Misoprostol
EXPERIMENTALPatients will be randomized to Misoprostol-alone in a 1:1 ratio prior to procedural abortions. A paracervical block of 20cc 1% lidocaine, with or without vasopressin, will be administered in accordance with standard practices.
Interventions
Eligibility Criteria
You may qualify if:
- English or Spanish-speaking
- Capacity to consent
- Seeking induced abortion of a singleton pregnancy
- Between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)
You may not qualify if:
- History of more than two prior Cesarean deliveries
- Sonographic evidence of placenta previa
- Sonographic concern for morbidly adherent placenta
- Prior obstetric hemorrhage requiring transfusion
- Obstructive cervical or lower uterine segment fibroid
- Current therapeutic anticoagulation use
- Cerclage in situ
- History of more than one prior cervical excisional procedure
- BMI greater than 50 kg/m\^2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
Related Publications (9)
Allen RH, Goldberg AB. Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation). Contraception. 2016 Apr;93(4):277-291. doi: 10.1016/j.contraception.2015.12.001. Epub 2015 Dec 9.
PMID: 26683499BACKGROUNDKapp N, Lohr PA, Ngo TD, Hayes JL. Cervical preparation for first trimester surgical abortion. Cochrane Database Syst Rev. 2010 Feb 17;2010(2):CD007207. doi: 10.1002/14651858.CD007207.pub2.
PMID: 20166091BACKGROUNDFox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11.
PMID: 24331860BACKGROUNDAshok PW, Flett GM, Templeton A. Mifepristone versus vaginally administered misoprostol for cervical priming before first-trimester termination of pregnancy: a randomized, controlled study. Am J Obstet Gynecol. 2000 Oct;183(4):998-1002. doi: 10.1067/mob.2000.106767.
PMID: 11035353BACKGROUNDBorgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.
PMID: 22682721BACKGROUNDOhannessian A, Baumstarck K, Maruani J, Cohen-Solal E, Auquier P, Agostini A. Mifepristone and misoprostol for cervical ripening in surgical abortion between 12 and 14 weeks of gestation: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016 Jun;201:151-5. doi: 10.1016/j.ejogrb.2016.04.007. Epub 2016 Apr 11.
PMID: 27132200BACKGROUNDDiedrich JT, Drey EA, Newmann SJ. Society of Family Planning clinical recommendations: Cervical preparation for dilation and evacuation at 20-24 weeks' gestation. Contraception. 2020 May;101(5):286-292. doi: 10.1016/j.contraception.2020.01.002. Epub 2020 Jan 31.
PMID: 32007418BACKGROUNDRanji, U., Diep, K., & Salganicoff, A. (2023). Key Facts on Abortion in the United States. Retrieved from https://www.kff.org/womens-health-policy/report/key-factson- abortion-in-the-united-states/#Where-do-people-get-abortion-care.
BACKGROUNDJones RK, Kirstein M, Philbin J. Abortion incidence and service availability in the United States, 2020. Perspect Sex Reprod Health. 2022 Dec;54(4):128-141. doi: 10.1363/psrh.12215. Epub 2022 Nov 20.
PMID: 36404279BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antoinette Danvers, MD, MSCR, MBA
Montefiore Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2024
First Posted
July 16, 2024
Study Start
October 31, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share