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Trial record 17 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

Doxycycline Prophylaxis at Vacuum Aspiration Trial (Tu Du Doxy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547170
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : May 16, 2008
Tu Du Hospital
Information provided by:
University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Endometritis Drug: Doxycycline pre-operatively Drug: Doxycycline post-operatively Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : January 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Infection [ Time Frame: 2 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00547170

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

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Responsible Party: Matthew Reeves, University of Pittsburgh Identifier: NCT00547170     History of Changes
Other Study ID Numbers: PRO06040005
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: May 16, 2008
Last Verified: May 2008
Keywords provided by University of Pittsburgh:
pelvic infection
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents