RecruitingNot ApplicableNCT05469984

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

Sponsor

Western Galilee Hospital-Nahariya

Enrollment

600 participants

Start Date

Nov 25, 2022

Study Type

INTERVENTIONAL

Conditions

Preterm Labor With Preterm Delivery Premature Rupture of Membranes Prolonged

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 48 Years

Inclusion Criteria1

Exclusion Criteria5

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

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Interventions

DRUGAmpicillin Only Product

women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin

DRUGampicillin plus gentamicin

women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin

Locations(1)

Galil Medical Center

Nahariya, Israel

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NCT05469984