Pain Control In First Trimester Medical Abortion: A Randomized Trial
PAIN CONTROL IN FIRST TRIMESTER MEDICAL ABORTION: A Randomized Trial
1 other identifier
interventional
250
1 country
2
Brief Summary
This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Oct 2011
2 active sites
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
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 20, 2011
CompletedFirst Posted
Study publicly available on registry
October 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
January 13, 2016
CompletedJanuary 13, 2016
October 1, 2015
1.2 years
October 20, 2011
August 11, 2015
December 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
11-point Visual Analog Scale for Pain
Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)
1-2 weeks
Study Arms (2)
Therapeutic
ACTIVE COMPARATORIbuprofen
Prophylactic
ACTIVE COMPARATORIbuprofen
Interventions
Eligibility Criteria
You may qualify if:
- Pregnant women with a gestational age of 63 days or less
- Desire a medical abortion with mifepristone and misoprostol
You may not qualify if:
- \- Have contraindications to ibuprofen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynuity Health Projectslead
- Society of Family Planningcollaborator
- Family Planning Associates Medical Group, LTDcollaborator
- Planned Parenthood of Greater New Yorkcollaborator
Study Sites (2)
Family Planning Associates Medical Group
Chicago, Illinois, 60630, United States
Planned Parenthood of New York City, Inc.
New York, New York, 10012, United States
Related Publications (2)
Reynolds-Wright JJ, Woldetsadik MA, Morroni C, Cameron S. Pain management for medical abortion before 14 weeks' gestation. Cochrane Database Syst Rev. 2022 May 13;5(5):CD013525. doi: 10.1002/14651858.CD013525.pub2.
PMID: 35553047DERIVEDRaymond EG, Weaver MA, Louie KS, Dean G, Porsch L, Lichtenberg ES, Ali R, Arnesen M. Prophylactic compared with therapeutic ibuprofen analgesia in first-trimester medical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Sep;122(3):558-64. doi: 10.1097/AOG.0b013e31829d5a33.
PMID: 23921857DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elizabeth Raymond
- Organization
- Gynuity Health Projects
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Raymond, MD, MPH
Gynuity Health Projects
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2011
First Posted
October 24, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 13, 2016
Results First Posted
January 13, 2016
Record last verified: 2015-10