Doxycycline Prophylaxis at Vacuum Aspiration Trial
- Conditions
- Endometritis
- Interventions
- Registration Number
- NCT00547170
- Lead Sponsor
- University of Pittsburgh
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Doxycycline post-operatively Half of enrolled women will be randomly assigned to group 2 1 Doxycycline pre-operatively Half of enrolled women will be randomly assigned to group 1.
- Primary Outcome Measures
Name Time Method Infection 2 weeks
- Secondary Outcome Measures
Name Time Method nausea and emesis 2 weeks compliance (completion of study medication) 5 days
Trial Locations
- Locations (1)
Tu Du Hospital
🇻🇳Ho Chi Minh City, Vietnam