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The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section

NCT02742948 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2016-04-19

No results posted yet for this study

Summary

Objective: To determine the optimal time for intravenous antibiotic prophylaxis administration in pregnant women undergoing elective cesarean section to minimize postpartum infectious complication for both the mother \& neonate.

Study Design: A randomized comparative study. Setting: The Obstetrics and Gynecology department of Kasr El Aini hospital (Cairo University - Egypt) in the period from April 2016 to September 2016.

Methodology: Six hundred pregnant women aged from 20 to 40 years old with singleton living healthy fetuses undergoing elective lower segment caesarean section (LSCS).They will be randomized into three groups: group A in which 200 women will receive IV ceftriaxone (2g) 60 minutes before skin incision, group B in which 200 women will receive IV ceftriaxone (2g) immediately with skin incision \& group C in which 200 women will receive IV ceftriaxone (2g) immediately after umbilical cord clamping. Outcomes include postoperative maternal \& fetal infectious morbidity.

Conditions

  • Endometritis

Interventions

DRUG

ceftriaxone

IV ceftriaxone (2g) will be given to all participants

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Moutaz Elsherbini, MD · Lecturer of obstetrics & gynaecology - Cairo university

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-08-31
Completion
2016-09-30

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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 NCT02742948 on ClinicalTrials.gov