Pain Control In First Trimester Medical Abortion: A Randomized Trial

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Ibuprofen

• Registration Number: NCT01457521
• Lead Sponsor: Gynuity Health Projects

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.

Detailed Description

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. Secondary objectives include comparing the regimens for the total amount of ibuprofen taken, use of other analgesics, vaginal bleeding, adverse events, successful completion of abortion, overall satisfaction with the abortion procedure.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-20
• Study First Submitted QC: 2011-10-21
• Study First Posted: 2011-10-24
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2015-08-11
• Status Verified: 2015-10
• Results First Submitted QC: 2015-12-10
• Last Update Submitted: 2015-12-10
• Results First Posted: 2016-01-13
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic	Ibuprofen	Ibuprofen
Prophylactic	Ibuprofen	Ibuprofen

Primary Outcome Measures

Name	Time	Method
11-point Visual Analog Scale for Pain	1-2 weeks	Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)

Trial Locations

Locations (2)

Family Planning Associates Medical Group; 🇺🇸 Chicago, Illinois, United States

Planned Parenthood of New York City, Inc.; 🇺🇸 New York, New York, United States