deltatrials
Recruiting PHASE4 INTERVENTIONAL 2-arm NCT05345457

Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age

Sponsor: MetroHealth Medical Center

Conditions PROM (Pregnancy) PROM, Preterm (Pregnancy) Pregnancy Preterm Pregnancy Prom Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor Premature Birth
Interventions Amoxicillin Pill Azithromycin Pill
Updated 9 times since 2022 Last updated: Apr 16, 2025 Started: Jan 13, 2023 Primary completion: Jun 30, 2026 Completion: Jun 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates PROM (Pregnancy) and PROM, Preterm (Pregnancy) and is currently actively recruiting participants. MetroHealth Medical Center leads this study, which shows 9 recorded versions since 2023 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~Mar 2023 · 59 days · monthly snapshot~Mar 2023 – ~Apr 2024 · 13 months · monthly snapshotRecruiting~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshotRecruiting~May 2025 – present · 14 months · monthly snapshotRecruiting

Change History

9 versions recorded

  1. May 2025 — Present [monthly]

    Recruiting PHASE4

  2. Sep 2024 — May 2025 [monthly]

    Recruiting PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE4

  4. Apr 2024 — Jul 2024 [monthly]

    Recruiting PHASE4

  5. Mar 2023 — Apr 2024 [monthly]

    Recruiting PHASE4

    Status: Not Yet Recruiting → Recruiting

▶ Show 4 earlier versions

  1. Jan 2023 — Mar 2023 [monthly]

    Not Yet Recruiting PHASE4

  2. Sep 2022 — Jan 2023 [monthly]

    Not Yet Recruiting PHASE4

  3. Jul 2022 — Sep 2022 [monthly]

    Not Yet Recruiting PHASE4

  4. May 2022 — Jul 2022 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • MetroHealth Medical Center
  • The Cleveland Clinic
  • University Hospitals Cleveland Medical Center
Data source: University Hospitals Cleveland Medical Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations