Endometritis
Conditions
Keywords
pelvic infection, abortion, doxycycline
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.
Interventions
DRUGDoxycycline pre-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)
DRUGDoxycycline post-operatively
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)
Sponsors
Tu Du Hospital
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
. 1. Women seeking elective surgical abortion 2. Gestational age 6 weeks 0 days to 12 weeks 6 days, confirmed by ultrasound. 3. Willing and able to sign an informed consent. 4. Willing to comply with the study protocol. 5. Age at enrollment of 18 years or more.
Exclusion criteria
1. Allergy to doxycycline or any tetracycline 2. Evidence of current pelvic infection 3. Breastfeeding 4. Current or recent use (within the past 7 days) of any other antibiotic. 5. Prior cardiac valve surgery or cardiac valve replacement. 6. Active use of alcohol, heroin, or cocaine. Post-enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infection | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| nausea and emesis | 2 weeks |
| compliance (completion of study medication) | 5 days |
Countries
Vietnam
Outcome results
None listed