Pain Control In First Trimester Medical Abortion: A Randomized Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Family Planning Associates Medical Group, Chicago, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

Ibuprofen

Primary outcomes

11-point Visual Analog Scale for Pain

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

Family Planning Associates Medical Group, LTD
Planned Parenthood of Greater New York
Society of Family Planning

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Oct 24, 2011
Registry last updated: Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed