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Pain control in first trimester medical abortion: A randomized trial

Elizabeth Raymond, Gynuity Health Projects/Reproductive Health Technologies Project, 2011
See also executive summary.

Project abstract

Although pain is a principal reason that women give for dissatisfaction with medical abortion, evidence about methods to control pain in this procedure is surprisingly scant. Because this pain can have a rapid progression, initiating analgesia before the onset of pain may produce a more satisfactory result than waiting until the pain occurs.

The proposed randomized trial will compare two regimens of ibuprofen: a treatment regimen consisting of ibuprofen 800 mg every 6 hours as needed for pain, and a prophylactic, “around-the-clock” regimen consisting of ibuprofen 800 mg starting 1 hour before the misoprostol dose, then four times a day for at least 2 days regardless of pain.

The study will include 250 women undergoing first trimester abortion at two large abortion facilities, Family Planning Associates Medical Group (Chicago, IL) and Planned Parenthood of New York City. After providing baseline data, each subject will be randomly assigned to one of the two regimens. She will keep a diary to record pain and other events until her scheduled abortion follow-up visit, at which outcome data will be obtained.

The primary outcome will be maximum pain as assessed on an 11-point numeric rating scale. Secondary outcomes will include total amount of ibuprofen taken, use of other analgesics, vaginal bleeding, adverse events, successful completion of abortion, and overall satisfaction with the abortion procedure.

The sample size of 250 subjects will provide 86% power to detect a mean difference between groups of 1.3 points on the pain severity scale. The study will be managed by Gynuity Health Projects, which has an extensive history conducting research to improve provision of medical abortion. We expect that our findings will provide guidance to clinicians and policy makers to improve abortion services in the United States and elsewhere.

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