Clinical Trial: Doxycycline Prophylaxis at Vacuum Aspiration Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial
Brief Summary: This study is a randomized, double-blinded, controlled trial comparing two regimens of doxycycline for the prevention of infection after surgical abortion. One thousand women undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du Hospital, Ho Chi Minh City, Vietnam. The standard regimen has been 100 mg twice daily for 5 days after the abortion. Subjects will be randomized to the standard regimen or to take 200 mg doxycycline pre-operatively. Subjects found to have a positive Chlamydia EIA test will receive a 7-day course of doxycycline regardless of study group. Subjects will complete questionnaires of symptoms, including nausea and emesis in the recovery room after the procedure and at a single follow-up visit two weeks later. The primary outcome will be infection after abortion, defined below. Analyses will be performed including and excluding Chlamydia-positive subjects. Secondary outcomes will be the proportion with nausea, emesis, and other side-effects.
Detailed Summary:
Sponsor: University of Pittsburgh
Current Primary Outcome: Infection [ Time Frame: 2 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- nausea and emesis [ Time Frame: 2 weeks ]
- compliance (completion of study medication) [ Time Frame: 5 days ]
Original Secondary Outcome: Same as current
Information By: University of Pittsburgh
Dates:
Date Received: October 19, 2007
Date Started: January 2007
Date Completion:
Last Updated: May 14, 2008
Last Verified: May 2008
