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Recruiting NCT05469984

NCT05469984 Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

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Clinical Trial Summary
NCT ID NCT05469984
Status Recruiting
Phase
Sponsor Western Galilee Hospital-Nahariya
Condition Preterm Labor With Preterm Delivery
Study Type INTERVENTIONAL
Enrollment 600 participants
Start Date 2022-11-25
Primary Completion 2025-09-25

Trial Parameters

Condition Preterm Labor With Preterm Delivery
Sponsor Western Galilee Hospital-Nahariya
Study Type INTERVENTIONAL
Phase N/A
Enrollment 600
Sex FEMALE
Min Age 18 Years
Max Age 48 Years
Start Date 2022-11-25
Completion 2025-09-25
Interventions
Ampicillin Only Productampicillin plus gentamicin

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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

Eligibility 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

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