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| Name | Class |
|---|---|
| Santa Clara Valley Health & Hospital System | OTHER |
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This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
After obtaining consent patients who sustained third or fourth degree perineal laceration after vaginal delivery were randomly assigned to a single dose of antibiotic (cefotetan or cefoxitin, 1 g intravenously or clindamycin, 900 mg intravenously, if allergic to penicillin), or placebo (100ml normal saline) intravenously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefotetan, Cefoxitin or Clindamycin | Active Comparator |
| |
| Normal Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefotetan or Cefoxitin vs placebo | Drug | Cefotetan or Cefoxitin, 1 g intravenously, or Clindamycin, 900 mg intravenously. Normal Saline, 100 ml intravenously for placebo arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| No perineal breakdown or infection | Six weeks post partum |
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Inclusion Criteria:
- third and fourth degree perineal laceration
Exclusion Criteria:
- chorioamnionitis, HIV positive, inflammatory bowel disease
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| Name | Affiliation | Role |
|---|---|---|
| Yasser Yehia El-Sayed | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Clara Valley Medical Center | San Jose | California | United States | |||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18515507 | Result | Duggal N, Mercado C, Daniels K, Bujor A, Caughey AB, El-Sayed YY. Antibiotic prophylaxis for prevention of postpartum perineal wound complications: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1268-73. doi: 10.1097/AOG.0b013e31816de8ad. |
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| ID | Term |
|---|---|
| D011251 | Pregnancy Complications, Infectious |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015313 | Cefotetan |
| ID | Term |
|---|---|
| D002513 | Cephamycins |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Stanford |
| California |
| 94305 |
| United States |
| Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |