An interventional study of Ampicillin Only Product and ampicillin plus gentamicin in Preterm Labor With Preterm Delivery and Premature Rupture of Membranes Prolonged, sponsored by Western Galilee Hospital-Nahariya. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 48 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Western Galilee Hospital-Nahariya · Not applicable, Interventional, and Prevention
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
Western Galilee Hospital-Nahariya is the lead sponsor of 87 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: maternal age > 18 years singleton pregnancy vertex presentation prolonged >18 h prom or preterm delivery
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Exclusion Criteria:
women with term prolonged \>18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery
Drug: Ampicillin Only Product · Drug: ampicillin plus gentamicin
women with term prolonged \>18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery plus IV gentamicin 5 mg/kg every 24 hours
Drug: Ampicillin Only Product · Drug: ampicillin plus gentamicin
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
endometritis 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
Plan to share: Undecided
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Western Galilee Hospital-Nahariya