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NCT01810354 · ClinicalTrials.gov registry record · NA
Prophylactic Antibiotics Prior TO Cesarean Section IN Obese Women
A NA study, sponsored by Women and Infants Hospital of Rhode Island.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
NCT01810354 is a NA study that has completed, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 58 participants.
The verdict
NCT01810354, a NA study, has completed, sponsored by Women and Infants Hospital of Rhode Island.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
Study Summary
Surgical site infections are common and a cause of major morbidity. They are also more common in obese women. Cesarean sections are the most common surgery performed in the United States, therefore pregnant women are being faced with this problem frequently. There is evidence to show that prophylactically administered antibiotics, cefazolin specifically, to obese women prior to cesarean section do not reach adequate concentrations in adipose tissue to prevent infection. The purpose of this study is to evaluate if an increased dose of cefazolin will attain adequate tissue concentration in obese women. Our hypothesis is that three grams of cefazolin given no more than 60 minutes prior to the start of a cesarean section in an obese (Body mass index (BMI) greater than or equal to 30) woman will attain adequate adipose tissue concentration compared to two grams of cefazolin. Subjects will be selected if they are greater than 37 weeks gestation wiht a singleton pregnancy and require a cesarean section for any obstetrical indication. Women will be excluded if they have a suspected infection, have a multiple gestation, or have preexisting diabetes or hypertension with end organ damage. The subjects will be screened both by through the OR schedule as well as through the clinics. They will then be consented and enrolled by the primary investigator. Once enrolled the subjects will be randomized to receive either two grams or three grams of cefazolin as prophylactic antibiotics to be given no more than 60 minutes prior to the start of the surgery. Two adipose tissue samples will be obtained at the time of surgery. The first at the start after skin incision and the second at the end prior to closure of the skin. There will also be a separate IV placed at the start of the procedure from which three blood draws can be collected. These three samples will be obtained at the start of the surgery but after antibiotic administration, at the time of the first adipose collection, and a
Interventions
- DRUG Cefazolin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01810354
The ClinicalTrials.gov registry entry for NCT01810354 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Women and Infants Hospital of Rhode Island, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cefazolin is the first listed.
NCT01810354 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01810354 about?
NCT01810354 is a clinical study titled "Prophylactic Antibiotics Prior TO Cesarean Section IN Obese Women". Surgical site infections are common and a cause of major morbidity. They are also more common in obese women. Cesarean sections are the most common surgery performed in the United States, therefore pregnant women are being faced with this problem frequently. There is evidence to show that prophylact...
What is the current status of trial NCT01810354?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2013-04. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01810354?
The interventions under investigation include: Cefazolin (DRUG).
Who is sponsoring clinical trial NCT01810354?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
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