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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
600
women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
Galil Medical Center
Nahariya, Israel
RECRUITINGendometritis rate
Time frame: up to 6 weeks postpartum
chorioamnionitis rate
Time frame: during labor (up to delivery of the newborn)
cord blood pH
Time frame: immediately after delivery of the placenta
maternal intrapartum fever
body temperature,
Time frame: during labor (up to delivery of the newborn)
NICU (neonatal intensive care unit) hospitalization length,
days
Time frame: up to 3 month from delivery
rate of neonatal early onset sepsis
positive blood culture
Time frame: up to one week from delivery
Rate of participants treated with antibiotics during the postpartum period
Time frame: 6 week postpartum
maternal postpartum hospitalization length
Time frame: up to 6 weeks post partum
Number of neonate with ventilation support
Time frame: one week from delivery
Number of neonate treated with antibiotics
Time frame: one week from delivery
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