Clinical Trial: The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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 g
Sponsor: Cairo University

Current Primary Outcome: endometritis [ Time Frame: up to 4 weeks postoperative ]

maternal axillary temperature ≥ 38°C for at least 48 hours, uterine tenderness, infected lochia & leukocytosis.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: March 30, 2016
Date Started: April 2016
Date Completion: September 2016
Last Updated: April 14, 2016
Last Verified: April 2016