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Doxycycline Prophylaxis at Vacuum Aspiration Trial (Tu Du Doxy)

This study has been completed.
Tu Du Hospital
Information provided by:
University of Pittsburgh Identifier:
First received: October 19, 2007
Last updated: May 14, 2008
Last verified: May 2008
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.

Condition Intervention Phase
Drug: Doxycycline pre-operatively
Drug: Doxycycline post-operatively
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Infection [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • nausea and emesis [ Time Frame: 2 weeks ]
  • compliance (completion of study medication) [ Time Frame: 5 days ]

Enrollment: 1000
Study Start Date: January 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Half of enrolled women will be randomly assigned to group 1.
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)
Active Comparator: 2
Half of enrolled women will be randomly assigned to group 2
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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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 Exclusion criteria

1) Abortion procedure not performed

  Contacts and Locations
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Please refer to this study by its identifier: NCT00547170

Tu Du Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
University of Pittsburgh
Tu Du Hospital
Principal Investigator: Matthew F Reeves, MD University of Pittsburgh
Study Director: Loi T Tran, MD Tu Du Hospital, Ho Chi Minh City, Vietnam
  More Information

Responsible Party: Matthew Reeves, University of Pittsburgh Identifier: NCT00547170     History of Changes
Other Study ID Numbers: PRO06040005
Study First Received: October 19, 2007
Last Updated: May 14, 2008

Keywords provided by University of Pittsburgh:
pelvic infection

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on May 25, 2017