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| Name | Class |
|---|---|
| Tu Du Hospital | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Half of enrolled women will be randomly assigned to group 1. |
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| 2 | Active Comparator | Half of enrolled women will be randomly assigned to group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline pre-operatively | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| nausea and emesis | 2 weeks | |
| compliance (completion of study medication) | 5 days |
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Inclusion Criteria.
Exclusion criteria
Post-enrollment Exclusion criteria
1) Abortion procedure not performed
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| Name | Affiliation | Role |
|---|---|---|
| Matthew F Reeves, MD | University of Pittsburgh | Principal Investigator |
| Loi T Tran, MD | Tu Du Hospital, Ho Chi Minh City, Vietnam | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tu Du Hospital | Ho Chi Minh City | Vietnam |
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| ID | Term |
|---|---|
| D004716 | Endometritis |
| D034161 | Pelvic Infection |
| ID | Term |
|---|---|
| D000292 | Pelvic Inflammatory Disease |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| Doxycycline post-operatively | Drug | 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) |
|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014591 | Uterine Diseases |
| D000091662 | Genital Diseases |
| D007239 | Infections |