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Trial record 4 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section

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ClinicalTrials.gov Identifier: NCT02742948
Recruitment Status : Unknown
Verified April 2016 by Moutaz Sherbini, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : April 19, 2016
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Moutaz Sherbini, Cairo University

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.


Condition or disease Intervention/treatment Phase
Endometritis Drug: ceftriaxone Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section: Randomized Comparative Study
Study Start Date : April 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Rocephin




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


Secondary Outcome Measures :
  1. neonatal immediate side effects [ Time Frame: within 24 hours postoperative ]
    diarrhea & fever

  2. neonatal sepsis [ Time Frame: up to 1 week postoperative ]
    clinical signs, leukocytosis, CRP & positive blood culture

  3. neonatal ICU admission [ Time Frame: within 24 hours postoperative ]
  4. Prolonged hospital stay [ Time Frame: 2 days ]
  5. wound infection [ Time Frame: up to 4 weeks postoperative ]
    induration, redness, hematoma, seroma or purulent discharge at the incision site

  6. urinary tract infection [ Time Frame: up to 4 weeks postoperative ]
    frequency, dysuria, suprapubic or loin pain & positive urine culture.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742948


Contacts
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Contact: MOUTAZ ELSHERBINI, MD (+2) 01001588300 mizosherbini@yahoo.com
Contact: rasha elkomy, MD (+2) 01001839383 md_rasha@hotmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Moutaz Elsherbini, MD Lecturer of obstetrics & gynaecology - Cairo university

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Responsible Party: Moutaz Sherbini, lecturer of obs& gyn, Cairo University
ClinicalTrials.gov Identifier: NCT02742948     History of Changes
Other Study ID Numbers: 821978
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Keywords provided by Moutaz Sherbini, Cairo University:
elective caesarean section
antibiotics
endometritis
Additional relevant MeSH terms:
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Endometritis
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Anti-Bacterial Agents
Ceftriaxone
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents