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Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section.

NCT02736682 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2016-04-13

No results posted yet for this study

Summary

Delivery by Cesarean section is increasing worldwide and this is the most important risk factor for post partum infection where there is a 5-20% risk of developing post partum infection than women who deliver vaginally Provision of single dose broad spectrum intravenous antibiotics 30-60 minutes before cesarean section has been found to be as effective as multiple doses in reducing post operative infections. At Mulago National referral Hospital mothers who have had elective and are at low risk of post partum infection also receive multiple doses of intravenous antibiotics for up to 7 days. The rationale of the study is to further inform us that single dose preoperative antibiotic prophylaxis is effective in prevention of post operative infection in mothers delivered by elective cesarean section.

Conditions

  • Post Operative Infections

Interventions

DRUG

Single dose antibiotic

Single dose arm receive 2g of IV Ceftriaxone and 500 mgs ofIntra venous Metronidazole given to the mothers 30-60 minutes pre operative.

DRUG

Multiple dose antibiotic

Multiple dose arm receive 1 g of IV Cetriaxone plus 500 mgs during surgery and there after IV ceftriaxone once a day for 3 days and IV Metronidazole 500mgs during surgery and there after every 8 hours for 3 days.

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Principal Investigators

  • Mugisa Alex Gideon, MBChB. · Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology

  • Paul Kiondo, MD, MMeD,PhD · Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology

  • Imelda Namagembe, MD, MMeD, MPH · Mulago NAtional Referral Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-02-29
Completion
2016-03-31

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02736682 on ClinicalTrials.gov