A Phase 4 interventional study of Doxycycline pre-operatively and Doxycycline post-operatively in Endometritis, sponsored by University of Pittsburgh. Completed at 1 site in Vietnam. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-05-16.
Sponsored by University of Pittsburgh · Phase 4, Interventional, and Prevention
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.
56 studies on the registry are indexed under Endometritis; 9 are open to participants now.
This study's enrollment of 1,000 is above the median of 202 across 42 interventional studies indexed under Endometritis.
Browse Endometritis studies →University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion criteria
Post-enrollment Exclusion criteria
1) Abortion procedure not performed
Half of enrolled women will be randomly assigned to group 1.
Drug: Doxycycline pre-operatively
Half of enrolled women will be randomly assigned to group 2
Drug: Doxycycline post-operatively
Two capsules of Doxycycline 100 mg before vacuum aspiration Placebo "100 mg" twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups)
Two capsules of placebo "100 mg" before vacuum aspiration Doxycycline 100 mg twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups)
Infection
Time frame: 2 weeks
nausea and emesis
Time frame: 2 weeks
compliance (completion of study medication)
Time frame: 5 days
The record gives a start of Jan 2007, a primary completion of Mar 2008 and a completion of Mar 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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