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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | August 28, 2009 | ||||
| Start Date ICMJE | September 2003 | ||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
No perineal breakdown or infection | ||||
| Original Primary Outcome Measures ICMJE |
No perineal breakdown or infection | ||||
| Change History | Complete list of historical versions of study NCT00186082 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE |
no perineal breakdown or infection [ Time Frame: 2 weeks ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs | ||||
| Official Title ICMJE | A Randomized Controlled Trial of the Effect of Prophylactic Antibiotics on the Infection Rate in Postpartum Third and Fourth Degree Perineal Tear Repairs | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Pregnancy Complications, Infectious | ||||
| Intervention ICMJE | Drug: Cefotetan or Cefoxitin vs placebo | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 147 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria::
Exclusion Criteria:- chorioamnionitis, HIV positive, inflammatory bowel disease |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00186082 | ||||
| Responsible Party | Yasser Yehia El-Sayed, Principal Investigator, Stanford University School of Medicine | ||||
| Study ID Numbers ICMJE | 95339 | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Santa Clara Valley Health & Hospital System | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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