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Clinical Trial Summary

This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity


Clinical Trial Description

Maternal peripartum fever is a common complication of pregnancy and postpartum period associated with potentially serious obstetrical outcomes and infectious morbidity. Peripartum infections includes intrapartum intraamniotic infection (IAI) and postpartum endometritis. Both are caused by polymicrobial bacterial infection. Increased latency period from rupture of membranes (ROM) until delivery is a common risk factor. Another risk factor is pre-term delivery. This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity. Primary outcome-peripartum infections- chorioamnionitis, endometritis and surgical site infection secondary outcome- obstetrical outcome- mode of delivery, Apgar score, cord blood pH, peripartum fever, maternal length of admission, postpartum maternal antibiotic treatment, Surface swab cultures were obtained from the placenta, amnion and umbilical cord (birth cultures) and uterine swab cultures, maternal blood culture, placental histologic evaluation neonatal outcomes-NICU admission, length of admission, neonatal morbidity-ventilation support, early neonatal sepsis ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05469984
Study type Interventional
Source Western Galilee Hospital-Nahariya
Contact Maya Wolf, MD
Phone 972-50-7887800
Email mayaw@gmc.gov.il
Status Not yet recruiting
Phase N/A
Start date September 2022
Completion date September 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05044143 - Prediction of Preterm Delivery With Serial Cervical Length Measurements After Threatened Preterm Labor
Recruiting NCT04846621 - Comparative Study Between Nicorandil and Nifedipine for the Treatment of Preterm Labour Phase 2