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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05345457
The ClinicalTrials.gov registry entry for NCT05345457 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 392-participant average among 38 other Premature Birth trials with a reported enrollment target (78% lower). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.