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

October 19, 2007
May 14, 2008
January 2007
March 2008   (final data collection date for primary outcome measure)
Infection [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Infection [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT00547170 on ClinicalTrials.gov Archive Site
  • 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 ]
  • nausea and emesis [ Time Frame: 2 weeks ]
  • compliance (completion of study medication) [ Time Frame: 5 days ]
Not Provided
Not Provided
 
Doxycycline Prophylaxis at Vacuum Aspiration Trial
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Endometritis
  • 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)
  • Experimental: 1
    Half of enrolled women will be randomly assigned to group 1.
    Intervention: Drug: Doxycycline pre-operatively
  • Active Comparator: 2
    Half of enrolled women will be randomly assigned to group 2
    Intervention: Drug: Doxycycline post-operatively
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
March 2008
March 2008   (final data collection date for primary outcome measure)

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

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Vietnam
 
NCT00547170
PRO06040005
No
Matthew Reeves, University of Pittsburgh
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
University of Pittsburgh
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP