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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2016 |
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Main ID: |
NCT02736682 |
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Date of registration:
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07/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section.
SDvMD |
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Scientific title:
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Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section in Mulago Hospital. A Randomized Clinical Trial. |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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174 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02736682 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Imelda Namagembe, MD, MMeD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mulago NAtional Referral Hospital |
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Name:
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Mugisa Alex Gideon, MBChB. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology |
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Name:
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Paul Kiondo, MD, MMeD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Antenatal mothers who have an indication for elective cesarean section in New Mulago
hospital.
Exclusion Criteria:
- Mothers who have a history of allergy to any of the drugs in the study, Mother with
visible infection at any site or elevated body temperature before going to theatre,
Those with rapture of membranes, Mothers who went into labor, Mother who has had use
of antibiotics in the last 7 days, WHO Clinical HIV stage III and IV and mothers who
do not consent to the study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Post Operative Infections
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Intervention(s)
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Drug: Multiple dose antibiotic
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Drug: Single dose antibiotic
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Primary Outcome(s)
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Post operative wound infections
[Time Frame: 14 days]
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Secondary Outcome(s)
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clinical endometritis
[Time Frame: 14 days]
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febrile morbidity
[Time Frame: 14 days]
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Secondary ID(s)
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2013/HD07/658U
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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