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

Not Applicable

Not yet recruiting

• Conditions: Preterm Labor With Preterm Delivery; Premature Rupture of Membranes Prolonged
• Interventions: Drug: Ampicillin Only Product; Drug: ampicillin plus gentamicin

• Registration Number: NCT05469984
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief 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

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-09
• Study First Submitted QC: 2022-07-19
• Last Update Submitted: 2022-07-19
• Study First Posted: 2022-07-22
• Last Update Posted: 2022-07-22
• Study Start: 2022-09
• Primary Completion: 2024-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

maternal age > 18 years singleton pregnancy vertex presentation prolonged >18 h prom or preterm delivery

Exclusion Criteria

• GBS carrier
• preterm premature rupture of membrane for conservative treatment
• intra-uterine fetal death fetal major anomaly
• drug allergy for the antibiotic in use in this study
• women receiving antibiotic treatment for other infection such as urinary tract infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
women with term prolonged>18h rupture of membrane	Ampicillin Only Product	women with term prolonged \>18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery
women with preterm labor	Ampicillin Only Product	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
women with preterm labor	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
women with term prolonged>18h rupture of membrane	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

Primary Outcome Measures

Name	Time	Method
endometritis rate	up to 6 weeks postpartum
chorioamnionitis rate	during labor (up to delivery of the newborn)

Secondary Outcome Measures

Name	Time	Method
cord blood pH	immediately after delivery of the placenta
NICU (neonatal intensive care unit) hospitalization length,	up to 3 month from delivery	days
maternal intrapartum fever	during labor (up to delivery of the newborn)	body temperature,
Number of neonate with ventilation support	one week from delivery
Number of neonate treated with antibiotics	one week from delivery
rate of neonatal early onset sepsis	up to one week from delivery	positive blood culture
neonatal APGAR score	at 1 and 5 minute post-delivery
Rate of participants treated with antibiotics during the postpartum period	6 week postpartum
maternal postpartum hospitalization length	up to 6 weeks post partum