Back to resultsDoxycycline Prophylaxis at Vacuum Aspiration Trial (Tu Du Doxy)
Primary Purpose
Endometritis
Status
Completed
Phase
Phase 4
Locations
Vietnam
Study Type
Interventional
Intervention
Doxycycline pre-operatively
Doxycycline post-operatively
Sponsored by
About this trial
This is an interventional prevention trial for Endometritis focused on measuring pelvic infection, abortion, doxycycline
Eligibility Criteria
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
Sites / Locations
- Tu Du Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Half of enrolled women will be randomly assigned to group 1.
Half of enrolled women will be randomly assigned to group 2
Outcomes
Primary Outcome Measures
Infection
Secondary Outcome Measures
nausea and emesis
compliance (completion of study medication)
Full Information
NCT ID
NCT00547170
First Posted
October 19, 2007
Last Updated
May 14, 2008
Sponsor
University of Pittsburgh
Collaborators
Tu Du Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00547170
Brief Title
Doxycycline Prophylaxis at Vacuum Aspiration Trial
Acronym
Tu Du Doxy
Official Title
Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
Collaborators
Tu Du Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometritis
Keywords
pelvic infection, abortion, doxycycline
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Half of enrolled women will be randomly assigned to group 1.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Half of enrolled women will be randomly assigned to group 2
Intervention Type
Drug
Intervention Name(s)
Doxycycline pre-operatively
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Doxycycline post-operatively
Intervention Description
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 Measure Information:
Title
Infection
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
nausea and emesis
Time Frame
2 weeks
Title
compliance (completion of study medication)
Time Frame
5 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew F Reeves, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Loi T Tran, MD
Organizational Affiliation
Tu Du Hospital, Ho Chi Minh City, Vietnam
Official's Role
Study Director
Facility Information:
Facility Name
Tu Du Hospital
City
Ho Chi Minh City
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
Doxycycline Prophylaxis at Vacuum Aspiration Trial
We'll reach out to this number within 24 hrs