Trial Comparing the Optimal Timing of Antibiotic Prophylaxis at the Time of Cesarean Delivery

NCT00811603 | Completed Phase 3 DMC

• 1 other identifier: 474-07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the rates of maternal and neonatal infectious morbidity in gravid patients undergoing cesarean delivery. Specifically, the investigators are examining whether the timing of antibiotic administration has any effect on rates of maternal and neonatal infections, neonatal sepsis work-up and length of hospital stay.

Conditions

Cesarean Section; Infection

Keywords

Antibiotic; Prophylaxis; Cesarean; Infection; Antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• To assess the rates of maternal infectious morbidity with preoperative administration of antibiotics when compared to antibiotic prophylaxis given following umbilical cord clamping

  6 weeks

Secondary Outcomes (1)

• To assess incidence of neonatal infectious morbidity (i.e. rates of sepsis work-up, confirmed sepsis, and length of hospital stay) between two study arms

  6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Patients who receive antibiotic prophylaxis after clamping of the umbilical cord

Drug: Cefazolin (Timing of Antibiotic Prophylaxis)

2

EXPERIMENTAL

Patients who receive antibiotic prophylaxis prior to skin incision

Drug: Cefazolin (Timing of Antibiotic Prophylaxis)

Interventions

Cefazolin (Timing of Antibiotic Prophylaxis) DRUG

Patients scheduled for a cesarean delivery will be randomly assigned to receive Cefazolin (antibiotic prophylaxis) either prior to skin incision or after the clamping of the umbilical cord

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older
• Any patient at term (\>37 weeks gestation) undergoing a scheduled cesarean delivery

You may not qualify if:

• Women younger than 18 years
• Patients who are febrile during or prior to screening or with a diagnosis of clinical suspicion of endometritis (with or without maternal fever)
• Patients who present with ruptured membranes
• Known fetal malformations
• Contraindications to cefazolin administration (known anaphylactic reaction to penicillins or known cephalosporin allergy)
• Any exposure to antibiotics in one week prior to cesarean delivery
• Obstetrical indication for an emergent cesarean delivery
• Patients taking glucocorticoids or other immunosuppressant therapy

Sponsors & Collaborators

• MemorialCare: lead
• University of California, Irvine: collaborator

Study Sites (2)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kenneth Chan, MD

  Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 19, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

US (2)