NCT02742948

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

4 months

First QC Date

March 30, 2016

Last Update Submit

April 14, 2016

Conditions

Endometritis

Keywords

elective caesarean sectionantibioticsendometritis

Outcome Measures

Primary Outcomes (1)

  • endometritis

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

    up to 4 weeks postoperative

Secondary Outcomes (6)

  • neonatal immediate side effects

    within 24 hours postoperative

  • neonatal sepsis

    up to 1 week postoperative

  • neonatal ICU admission

    within 24 hours postoperative

  • Prolonged hospital stay

    2 days

  • wound infection

    up to 4 weeks postoperative

  • +1 more secondary outcomes

Study Arms (3)

preoperative antibiotic group

ACTIVE COMPARATOR

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

Drug: ceftriaxone

early intraoperative antibiotic group

ACTIVE COMPARATOR

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

Drug: ceftriaxone

post cord clamping antibiotic group

ACTIVE COMPARATOR

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

Drug: ceftriaxone

Interventions

ceftriaxoneDRUG

IV ceftriaxone (2g) will be given to all participants

Also known as: Rocephin
early intraoperative antibiotic grouppost cord clamping antibiotic grouppreoperative antibiotic group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometritis

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Pelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Moutaz Elsherbini, MD

    Lecturer of obstetrics & gynaecology - Cairo university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MOUTAZ ELSHERBINI, MD

CONTACT

(+2) 01001588300mizosherbini@yahoo.com

rasha elkomy, MD

CONTACT

(+2) 01001839383md_rasha@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obs& gyn

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 19, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04