Doxycycline Prophylaxis at Vacuum Aspiration Trial (Tu Du Doxy)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Design

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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

Arms and Interventions

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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)

Outcome Measures

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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 ]

Eligibility Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Matthew Reeves, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00547170 History of Changes
Other Study ID Numbers:	PRO06040005
First Posted:	October 22, 2007
Last Update Posted:	May 16, 2008
Last Verified:	May 2008

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