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NCT01457521 Clinical Trial

Pain Control In First Trimester Medical Abortion: A Randomized Trial

Pain Clinical Trial

Official title:
PAIN CONTROL IN FIRST TRIMESTER MEDICAL ABORTION: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01457521
Other study ID # 1000
Secondary ID
Status Completed
Phase Phase 4
First received October 20, 2011
Last updated December 10, 2015
Start date October 2011
Est. completion date December 2012

Study information
Verified date October 2015
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ibuprofen
Ibuprofen

Locations
Country Name City State
United States Family Planning Associates Medical Group Chicago Illinois
United States Planned Parenthood of New York City, Inc. New York New York

Sponsors (4)
Lead Sponsor Collaborator
Gynuity Health Projects Family Planning Associates Medical Group, LTD, Planned Parenthood of New York City, Inc., Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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