Galil Medical Center
Nahariya, Israel
Location status: Recruiting
NCT Number: NCT05469984
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
Interested in participating?
Request Info18 year–48 year
Female
Interventional
Not applicable
Nahariya, Israel
Location status: Recruiting
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
maternal age > 18 years singleton pregnancy vertex presentation prolonged >18 h prom or preterm delivery
-
Exclusion criteria
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
Time frame: up to 6 weeks postpartum
Time frame: during labor (up to delivery of the newborn)
Time frame: immediately after delivery of the placenta
Time frame: during labor (up to delivery of the newborn)
body temperature,
Time frame: up to 3 month from delivery
days
Time frame: up to one week from delivery
positive blood culture
Time frame: 6 week postpartum
Time frame: up to 6 weeks post partum
Time frame: one week from delivery
Time frame: one week from delivery
Contact information is provided by the study sponsor or research team.
Western Galilee Hospital-Nahariya
Other Gov
Comparing Obstetrical Outcomes and Infectious Morbidity Between Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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