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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated August 6, 2025 (before its estimated September 25, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 200 to 600v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Sep 2024 to Sep 25, 2025
    • Study sites: 0 to 1
    • Study completion date: Sep 2025 to Sep 26, 2025
    • Start date changed from estimate of Sep 2022 to Nov 25, 2022
    • Secondary endpoints: 9 to 8
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05469984
Lead Sponsor Western Galilee Hospital-Nahariya
Conditions
(from sponsor)		 Preterm Labor With Preterm Delivery, Premature Rupture of Membranes Prolonged
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov