Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation
MMSAP
A Randomized Comparison of Same-Day Oral Mifepristone-Misoprostol to Misoprostol Only for Cervical Preparation in Second Trimester Surgical Abortion
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedResults Posted
Study results publicly available
March 2, 2022
CompletedMarch 2, 2022
February 1, 2022
1.3 years
March 13, 2015
January 13, 2017
February 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Initial Cervical Dilation
Initial cervical dilation as measured by Hegar Dilator accepted with least resistance
Assessed 4-6 hour following medications at time of D&E procedure
Secondary Outcomes (1)
Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)
intraoperative
Study Arms (2)
Mifepristone
ACTIVE COMPARATORMifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once
Placebo
PLACEBO COMPARATORPlacebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
Interventions
Eligibility Criteria
You may qualify if:
- healthy women
- eligible for non---urgent D\&E
- /7 weeks to 19 6/7 weeks gestation, confirmed by sonogram
You may not qualify if:
- emergent need for D\&E
- fetal demise
- intolerance
- allergy or contraindication to mifepristone or misoprostol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Casey FE, Ye PP, Perritt JD, Moreno-Ruiz NL, Reeves MF. A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion. Contraception. 2016 Aug;94(2):127-33. doi: 10.1016/j.contraception.2016.02.032. Epub 2016 Mar 4.
PMID: 26948184DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Frances Casey
- Organization
- VCU Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2015
First Posted
April 9, 2015
Study Start
September 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
March 2, 2022
Results First Posted
March 2, 2022
Record last verified: 2022-02