The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section

April 14, 2016 updated by: Moutaz Sherbini, Cairo University

The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section: Randomized Comparative Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Six hundred pregnant women aged from 20 to 40 years old with singleton living healthy fetuses undergoing elective lower segment caesarean section (LSCS); defined as LSCS done before onset of labor pains, will be enrolled in the study. 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. Randomization will be done using computer generated random numbers.

Another inclusion criterion includes gestational age (GA) more than 37 weeks gestation. Patients on immunosuppressant drugs, received any antibiotic prophylaxis (within 10 days), suffer any chronic illness (e.g. diabetes mellitus or renal disease) or who experienced any obstetric complication in the current pregnancy (e.g. antepartum hemorrhage & rupture of membranes) will be excluded from the study. Additional exclusion criteria include previous history of more than two laparotomies, maternal BMI more than 28 & any maternal febrile illness within 10 days from the procedure. Patients who are known to be allergic to penicillin or cephalosporin will be also excluded (all patients will receive 100 mg of ceftriaxone as a test dose before participation in the current study). The study was approved by the Hospital Ethical Committee. All participants will provide an informed consent after explaining the aim and potential hazards of the study.

For all patients, full history will be taken followed by complete physical examination, obstetric ultrasound & routine preoperative investigations. GA is established by menstrual dates then confirmed by obstetric ultrasound. Spinal anaesthesia will be given for all patients. All cesarean sections will be done by ob/gyn residents under the supervision of senior staff obstetrician using the following technique: Pfannenstiel skin incision, transverse lower uterine segment incision, two-layer closure of the uterine wall, closure of both parietal peritoneum & rectus sheath & skin closure (using prolene 3/0 suture). Primary maternal outcome includes postoperative endometritis (diagnosed if maternal axillary temperature ≥ 38°C for at least 48 hours, uterine tenderness, infected lochia & leukocytosis).Secondary maternal outcomes include wound infection (diagnosed if there is induration, redness, hematoma, seroma or purulent discharge at the incision site) & urinary tract infection (diagnosed if there frequency, dysuria, suprapubic or loin pain & positive urine culture). Prolonged postoperative hospital stay (more than 2 days) will also be recorded. The infectious morbidity evaluation will be done by ob/gyn residents who will be blinded to the study group of the patient. Neonatal outcomes include immediate antibiotic adverse effects (diarrhea & rash), neonatal sepsis (diagnosed by clinical signs, leukocytosis, C-reactive protein& positive blood culture), neonatal intensive care unit (NICU) admission (entailing the length of stay) & neonatal death. All neonates will be examined by an expert neonatologist who will be blinded to study group of the neonate's mother. On discharging all patients, a brief summary about symptoms and signs of the above mentioned infectious & neonatal complications will be given and they will be instructed to contact any of the authors immediately if any happens. Patients will be reexamined after 1 week (skin stitch removal appointment) & 4 weeks (contraception counseling appointment) following the CS.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women in singleton living healthy fetuses. gestational age (GA) more than 37 weeks gestation

Exclusion Criteria:

  • Patients on immunosuppressant drugs, received any antibiotic prophylaxis (within 10 days), suffer any chronic illness (e.g. diabetes mellitus or renal disease) or who experienced any obstetric complication in the current pregnancy (e.g. antepartum hemorrhage & rupture of membranes). Previous history of more than two laparotomies, maternal BMI more than 28 & any maternal febrile illness within 10 days from the procedure. Patients who are known to be allergic to penicillin or cephalosporin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: preoperative antibiotic group
200 women will receive IV ceftriaxone (2g) 60 minutes before skin incision
Drug: ceftriaxone
IV ceftriaxone (2g) will be given to all participants
Other Names:
  • Rocephin
Active Comparator: early intraoperative antibiotic group
200 women will receive IV ceftriaxone (2g) immediately with skin incision
Drug: ceftriaxone
IV ceftriaxone (2g) will be given to all participants
Other Names:
  • Rocephin
Active Comparator: post cord clamping antibiotic group
200 women will receive IV ceftriaxone (2g) immediately after umbilical cord clamping
Drug: ceftriaxone
IV ceftriaxone (2g) will be given to all participants
Other Names:
  • Rocephin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endometritis
Time Frame: up to 4 weeks postoperative
maternal axillary temperature ≥ 38°C for at least 48 hours, uterine tenderness, infected lochia & leukocytosis.
up to 4 weeks postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal immediate side effects
Time Frame: within 24 hours postoperative
diarrhea & fever
within 24 hours postoperative
neonatal sepsis
Time Frame: up to 1 week postoperative
clinical signs, leukocytosis, CRP & positive blood culture
up to 1 week postoperative
neonatal ICU admission
Time Frame: within 24 hours postoperative
within 24 hours postoperative
Prolonged hospital stay
Time Frame: 2 days
2 days
wound infection
Time Frame: up to 4 weeks postoperative
induration, redness, hematoma, seroma or purulent discharge at the incision site
up to 4 weeks postoperative
urinary tract infection
Time Frame: up to 4 weeks postoperative
frequency, dysuria, suprapubic or loin pain & positive urine culture.
up to 4 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Moutaz Elsherbini, MD, Lecturer of obstetrics & gynaecology - Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 821978

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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