NCT05469984

Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

Comparing Obstetrical Outcomes and Infectious Morbidity Between Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Preterm Labor With Preterm Delivery
• Premature Rupture of Membranes Prolonged

Interventions

Type	Name	Description
DRUG	Ampicillin Only Product	women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
DRUG	ampicillin plus gentamicin	women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin

Timeline

• Start date: 2022-11-25
• Primary completion: 2025-09-25
• Completion: 2025-09-26
• First posted: 2022-07-22
• Last updated: 2025-08-06

Locations

1 site across 1 country: Israel