Doxycycline Prophylaxis at Vacuum Aspiration Trial (Tu Du Doxy)
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| ClinicalTrials.gov Identifier: NCT00547170 |
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Recruitment Status :
Completed
First Posted : October 22, 2007
Last Update Posted : May 16, 2008
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Sponsor:
University of Pittsburgh
Collaborator:
Tu Du Hospital
Information provided by:
University of Pittsburgh
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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 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
MedlinePlus related topics:
Nausea and Vomiting
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Half of enrolled women will be randomly assigned to group 1.
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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) |
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Active Comparator: 2
Half of enrolled women will be randomly assigned to group 2
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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 :
- Infection [ Time Frame: 2 weeks ]
Secondary Outcome Measures :
- nausea and emesis [ Time Frame: 2 weeks ]
- compliance (completion of study medication) [ Time Frame: 5 days ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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 ClinicalTrials.gov identifier (NCT number): NCT00547170
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 |
| Responsible Party: | Matthew Reeves, University of Pittsburgh |
| ClinicalTrials.gov 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:
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pelvic infection abortion doxycycline |
Additional relevant MeSH terms:
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Pelvic Inflammatory Disease Adnexal Diseases Genital Diseases, Female Uterine Diseases Endometritis Doxycycline |
Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |