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NCT05345457 · ClinicalTrials.gov registry record · Phase 4
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
A Phase 4 study of Premature Birth and Pregnancy Preterm, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 88
- Enrollment target
- 3
- Study locations
NCT05345457: Recruiting Phase 4 study of Premature Birth and Pregnancy Preterm, sponsored by University Hospitals Cleveland Medical Center.
NCT05345457 is a Phase 4 study of Premature Birth and Pregnancy Preterm that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 88 participants, below the 392-participant average among 38 other Premature Birth trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05345457, a Phase 4 study of Premature Birth and Pregnancy Preterm, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 88 participants
- Enrollment target
- 3
- Study locations
Study Summary
A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.
Primary Outcome
The proportion of patients that undergo a spontaneous or medically-indicated delivery within 28 days from diagnosis of previable prelabor rupture of membranes (pPPROM)
Conditions Studied
Interventions
- DRUG Azithromycin Pill
- DRUG Amoxicillin Pill
Study Locations (3)
Ohio
- University Hospitals - Cleveland
- MetroHealth - Cleveland
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2023-01-13 |
| Est. Completion | 2027-06 |
| Phase | Phase 4 |
What NCT05345457 shows while recruiting
NCT05345457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 392-participant average among 38 other Premature Birth trials with a reported enrollment target (78% lower).
The record links to 6 conditions, with Premature Birth appearing as the primary indexed condition, and to 2 interventions - of which Azithromycin Pill is the first listed.
NCT05345457 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05345457 about?
NCT05345457 is a clinical study titled "Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age". A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/...
What is the current status of trial NCT05345457?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2023-01-13. Estimated completion is 2027-06.
What conditions does trial NCT05345457 study?
This clinical trial studies the following conditions: Premature Birth, Pregnancy Preterm, Pregnancy Prom, PROM, Preterm (Pregnancy), PROM (Pregnancy).
What interventions are being tested in trial NCT05345457?
The interventions under investigation include: Azithromycin Pill (DRUG), Amoxicillin Pill (DRUG).
Who is sponsoring clinical trial NCT05345457?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05345457 being conducted?
This trial has 3 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Premature Birth
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05345457's enrollment target sits among peer trials
88 26th of 38 higher than 13 of 38 other Premature Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Premature Birth trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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