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
About this trial
This is an interventional prevention trial for Endometritis focused on measuring elective caesarean section, antibiotics, endometritis
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
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
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
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The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section
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