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Doxycycline Prophylaxis at Vacuum Aspiration Trial (Tu Du Doxy)

This study has been completed.
Sponsor:
Collaborator:
Tu Du Hospital
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00547170
First received: October 19, 2007
Last updated: May 14, 2008
Last verified: May 2008
History of Changes
  Purpose
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
Endometritis
 Drug: Doxycycline pre-operatively
Drug: Doxycycline post-operatively
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Infection [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • nausea and emesis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • compliance (completion of study medication) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
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)

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547170

Locations
Vietnam
Tu Du Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
University of Pittsburgh
Tu Du Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT00547170     History of Changes
Other Study ID Numbers: PRO06040005 
Study First Received: October 19, 2007
Last Updated: May 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
pelvic infection
abortion
doxycycline

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Endometritis
Doxycycline
 Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on September 29, 2016