Doxycycline Prophylaxis at Vacuum Aspiration Trial (Tu Du Doxy)

University of Pittsburgh

Status and phase: Completed; Phase 4

Conditions: Endometritis

Treatments: Drug: Doxycycline pre-operatively; Drug: Doxycycline post-operatively

Study type: Interventional

Funder types: Other

Identifiers

NCT00547170

PRO06040005

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 Exclusion criteria

1. Abortion procedure not performed

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups

1

Experimental group

Description:

Half of enrolled women will be randomly assigned to group 1.

Treatment:

Drug: Doxycycline pre-operatively

2

Active Comparator group

Description:

Half of enrolled women will be randomly assigned to group 2

Treatment:

Drug: Doxycycline post-operatively