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| Sponsors and Collaborators: |
University of Pittsburgh Tu Du Hospital |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00547170 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Endometritis |
Drug: Doxycycline pre-operatively Drug: Doxycycline post-operatively |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial |
| Enrollment: | 1000 |
| Study Start Date: | January 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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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2: Active Comparator
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)
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria.
Exclusion criteria
Post-enrollment Exclusion criteria
1) Abortion procedure not performed
Contacts and Locations| Vietnam | |
| Tu Du Hospital | |
| Ho Chi Minh City, Vietnam | |
| 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
| Responsible Party: | University of Pittsburgh ( Matthew Reeves ) |
| Study ID Numbers: | PRO06040005 |
| Study First Received: | October 19, 2007 |
| Last Updated: | May 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00547170 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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pelvic infection abortion doxycycline |
|
Genital Diseases, Female Antimalarials Anti-Bacterial Agents Endometritis |
Uterine Diseases Pelvic Inflammatory Disease Pelvic Infection Doxycycline |
|
Anti-Infective Agents Antiprotozoal Agents Endometritis Uterine Diseases Pelvic Inflammatory Disease Pharmacologic Actions Adnexal Diseases |
Genital Diseases, Female Anti-Bacterial Agents Antimalarials Antiparasitic Agents Therapeutic Uses Doxycycline |
