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

Western Galilee Hospital-Nahariya

Status: Not yet enrolling

Conditions: Preterm Labor With Preterm Delivery; Premature Rupture of Membranes Prolonged

Treatments: Drug: ampicillin plus gentamicin; Drug: Ampicillin Only Product

Study type: Interventional

Funder types: Other

Identifiers

NCT05469984

0103-22-NHR

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

women with term prolonged>18h rupture of membrane

Active Comparator group

Description:

women with term prolonged \>18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery

Treatment:

Drug: ampicillin plus gentamicin

Drug: Ampicillin Only Product

women with preterm labor

Active Comparator group

Description:

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

Treatment:

Drug: ampicillin plus gentamicin

Drug: Ampicillin Only Product