search
Back to results

The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section

Primary Purpose

Endometritis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ceftriaxone
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endometritis focused on measuring elective caesarean section, antibiotics, endometritis

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    preoperative antibiotic group

    early intraoperative antibiotic group

    post cord clamping antibiotic group

    Arm Description

    200 women will receive IV ceftriaxone (2g) 60 minutes before skin incision

    200 women will receive IV ceftriaxone (2g) immediately with skin incision

    200 women will receive IV ceftriaxone (2g) immediately after umbilical cord clamping

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    neonatal immediate side effects
    diarrhea & fever
    neonatal sepsis
    clinical signs, leukocytosis, CRP & positive blood culture
    neonatal ICU admission
    Prolonged hospital stay
    wound infection
    induration, redness, hematoma, seroma or purulent discharge at the incision site
    urinary tract infection
    frequency, dysuria, suprapubic or loin pain & positive urine culture.

    Full Information

    First Posted
    March 30, 2016
    Last Updated
    April 14, 2016
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02742948
    Brief Title
    The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section
    Official Title
    The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section: Randomized Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    August 2016 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometritis
    Keywords
    elective caesarean section, antibiotics, endometritis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    preoperative antibiotic group
    Arm Type
    Active Comparator
    Arm Description
    200 women will receive IV ceftriaxone (2g) 60 minutes before skin incision
    Arm Title
    early intraoperative antibiotic group
    Arm Type
    Active Comparator
    Arm Description
    200 women will receive IV ceftriaxone (2g) immediately with skin incision
    Arm Title
    post cord clamping antibiotic group
    Arm Type
    Active Comparator
    Arm Description
    200 women will receive IV ceftriaxone (2g) immediately after umbilical cord clamping
    Intervention Type
    Drug
    Intervention Name(s)
    ceftriaxone
    Other Intervention Name(s)
    Rocephin
    Intervention Description
    IV ceftriaxone (2g) will be given to all participants
    Primary Outcome Measure Information:
    Title
    endometritis
    Description
    maternal axillary temperature ≥ 38°C for at least 48 hours, uterine tenderness, infected lochia & leukocytosis.
    Time Frame
    up to 4 weeks postoperative
    Secondary Outcome Measure Information:
    Title
    neonatal immediate side effects
    Description
    diarrhea & fever
    Time Frame
    within 24 hours postoperative
    Title
    neonatal sepsis
    Description
    clinical signs, leukocytosis, CRP & positive blood culture
    Time Frame
    up to 1 week postoperative
    Title
    neonatal ICU admission
    Time Frame
    within 24 hours postoperative
    Title
    Prolonged hospital stay
    Time Frame
    2 days
    Title
    wound infection
    Description
    induration, redness, hematoma, seroma or purulent discharge at the incision site
    Time Frame
    up to 4 weeks postoperative
    Title
    urinary tract infection
    Description
    frequency, dysuria, suprapubic or loin pain & positive urine culture.
    Time Frame
    up to 4 weeks postoperative

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MOUTAZ ELSHERBINI, MD
    Phone
    (+2) 01001588300
    Email
    mizosherbini@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    rasha elkomy, MD
    Phone
    (+2) 01001839383
    Email
    md_rasha@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Moutaz Elsherbini, MD
    Organizational Affiliation
    Lecturer of obstetrics & gynaecology - Cairo university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section

    We'll reach out to this number within 24 hrs