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

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.

Study Type: Interventional

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

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: Doxycycline 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)
• Drug: Doxycycline 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)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Half of enrolled women will be randomly assigned to group 1.
• Active Comparator: 2
  • Half of enrolled women will be randomly assigned to group 2

Primary Measures

• Infection
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• nausea and emesis
  • Time Frame: 2 weeks
    Safety Issue?: No
• compliance (completion of study medication)
  • Time Frame: 5 days
    Safety Issue?: 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

Exclusion criteria

• 1) Abortion procedure not performed

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Matthew F Reeves, MD Principal Investigator University of Pittsburgh  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547170

Study ID Number: PRO06040005

ClinicalTrials.gov Identifier: NCT00547170

Health Authority: United States: Institutional Review Board