Phase 4 N=250 Randomized Treatment

Pain Control In First Trimester Medical Abortion: A Randomized Trial

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01457521 ↗

Enrolled (actual)

250

Serious AEs

0.0%

Results posted

Jan 2016

Primary outcome: Primary: 11-point Visual Analog Scale for Pain — 7.1; 7.3 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ibuprofen (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Gynuity Health Projects
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY 11-point Visual Analog Scale for Pain	7.1; 7.3	—

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.

Eligibility Criteria

Inclusion Criteria

Pregnant women with a gestational age of 63 days or less
Desire a medical abortion with mifepristone and misoprostol

Exclusion Criteria

Have contraindications to ibuprofen

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01457521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.