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Effect of administration of cefazolin in cesarean delivery on maternal postoperative infections and early neonatal complications

Comparison of single dose cefazolin versus single dose cefazolin plus seven days cephalexin prophylactic therapy on postoperative infections and early neonatal complications after elective cesarean section

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201506084339N10
Enrollment
204
Registered
2015-07-10
Start date
2015-05-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early neonatal complications (rash, diarrhea, oral candidiasis) and maternal infections after elective cesarean section. Antibiotics associated rash, diarrhea and oral candidiasis in neonate and maternal genitourinary and surgical site infections

Interventions

Intervention 1: Control group: administrating cefazolin 1gr IV after clamping umbilical cord plus oral cephalexin 500 mg QID for seven days to mothers. Intervention 2: Intervention group: administrat
Treatment - Drugs
Prevention
Control group: administrating cefazolin 1gr IV after clamping umbilical cord plus oral cephalexin 500 mg QID for seven days to mothers.
Intervention group: administrating cefazolin 1gr IV to mothers after clamping umblical cord.

Sponsors

Vice chancellor of research, Bushehr University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Inclusion criteria: primi gravid; normal BMI Exclusion criteria: Obese women; history of antibiotic consumption in one week prior to cesarean section; immunosuppression; history of corticosteroid consumption; neonates with meconium stained amniotic fluid; duration of operation more than 30 minutes; patients with comorbidity.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Diarrhea, rash and oral candidiasis in neonate. Timepoint: During first 48 hours after delivery and one week postdelivery. Method of measurement: History and physical examination.

Secondary

MeasureTime frame
Surgical site infection. Timepoint: During first 48 hours post delivery and one week post delivery. Method of measurement: History, physical examination.;Metritis. Timepoint: During first 48 hours post delivery and one week post delivery. Method of measurement: History, physical examination.;Urinary tract infection. Timepoint: During first 48 hours post delivery and one week post delivery. Method of measurement: History, physical examination, urinalysis and urine culture.;Breastfeeding satisfaction. Timepoint: During first 48 hours post delivery and one week post delivery. Method of measurement: History.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Elham Rahmani

Bushehr University of Medical Sciences

rahmani@bpums.ac.ir+98 77 3345 5374

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026