Doxycycline Prophylaxis at Vacuum Aspiration Trial

Condition(s) targeted: Endometritis

Intervention: Doxycycline pre-operatively (Drug); Doxycycline post-operatively (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Matthew F Reeves, MD, Principal Investigator, Affiliation: University of Pittsburgh
Loi T Tran, MD, Study Director, Affiliation: Tu Du Hospital, Ho Chi Minh City, Vietnam

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.

Official title: Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Infection

Secondary outcome:

nausea and emesis

compliance (completion of study medication)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Tu Du Hospital, Ho Chi Minh City, Vietnam

Starting date: January 2007
Ending date: March 2008
Last updated: May 14, 2008