- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00547170
Doxycycline Prophylaxis at Vacuum Aspiration Trial (Tu Du Doxy)
May 14, 2008 updated by: University of Pittsburgh
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ho Chi Minh City, Vietnam
- Tu Du Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria.
- Women seeking elective surgical abortion
- Gestational age 6 weeks 0 days to 12 weeks 6 days, confirmed by ultrasound.
- Willing and able to sign an informed consent.
- Willing to comply with the study protocol.
- Age at enrollment of 18 years or more.
Exclusion criteria
- Allergy to doxycycline or any tetracycline
- Evidence of current pelvic infection
- Breastfeeding
- Current or recent use (within the past 7 days) of any other antibiotic.
- Prior cardiac valve surgery or cardiac valve replacement.
- Active use of alcohol, heroin, or cocaine.
Post-enrollment Exclusion criteria
1) Abortion procedure not performed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Half of enrolled women will be randomly assigned to group 1.
|
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
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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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infection
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
nausea and emesis
Time Frame: 2 weeks
|
2 weeks
|
compliance (completion of study medication)
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew F Reeves, MD, University of Pittsburgh
- Study Director: Loi T Tran, MD, Tu Du Hospital, Ho Chi Minh City, Vietnam
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
October 19, 2007
First Submitted That Met QC Criteria
October 19, 2007
First Posted (Estimate)
October 22, 2007
Study Record Updates
Last Update Posted (Estimate)
May 16, 2008
Last Update Submitted That Met QC Criteria
May 14, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO06040005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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