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NCT04047849 · ClinicalTrials.gov registry record · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
A Phase 4 study of Preterm Birth and Preterm Labor, sponsored by Woman's.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT04047849 is a Phase 4 study of Preterm Birth and Preterm Labor that is actively recruiting participants, run by Woman's. The registered enrollment target is 34 participants, below the 4,629-participant average among 37 other Preterm Birth trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04047849, a Phase 4 study of Preterm Birth and Preterm Labor, is actively recruiting participants, sponsored by Woman's.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a non-blinded, prospective, randomized controlled trial designed to compare the effect of outpatient oral antibiotics (i.e., amoxicillin and azithromycin) on the length of time (days) that pregnancy continues after a patient's water bag has ruptured prematurely. If a patient has been diagnosed with rupture of their water bag between 18 0/7 weeks and 22 6/7 weeks and there are no other associated complications with the pregnancy, the patient is eligible for initial consideration for this study. Patients will be admitted to the hospital for a 24-hour monitoring period. If the patient remains without further complications during this monitoring period, the patient will be eligible for enrollment. If enrollment is desired, the patient will be randomly assigned to receive either antibiotics (treatment arm of the study) or no antibiotics (control arm of the study). The treatment arm will receive an outpatient, 7-day course of oral antibiotics (azithromycin and amoxicillin) with the first dose given in the hospital to ensure no side effects. The control arm will not receive outpatient antibiotics. Both groups will have weekly, office follow-up visits with high-risk pregnancy specialists to ensure no further complications. Both groups will be admitted to the hospital if the patients reach 23 0/7 weeks without complications. At this time the patients will receive all medications and therapies recommended by the governing board of OBGYNs. Subjects of both groups will also be admitted before 23 0/7 weeks if further complications noted either at their clinic follow up visits or anytime outside of the hospital. The duration of time that the patient remains pregnant after breaking of the water bag will be compared in each group. The investigators will also see if there is a difference in the number of patients able to reach 23 0/7 weeks between each group (treatment versus control).
Conditions Studied
Interventions
- DRUG Antibiotics, oral Azithromycin and oral Amoxicillin
Study Locations (1)
Louisiana
- Woman's Hospital - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-08-28 |
| Est. Completion | 2021-07-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04047849
The ClinicalTrials.gov registry entry for NCT04047849 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,629-participant average among 37 other Preterm Birth trials with a reported enrollment target (99% lower). The listed sponsor is Woman's, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Preterm Birth appearing as the primary indexed condition, and to 1 intervention - of which Antibiotics, oral Azithromycin and oral Amoxicillin is the first listed.
NCT04047849 reports 1 study location spanning 1 distinct geographic area - top geographies include Louisiana.
Frequently Asked Questions
What is clinical trial NCT04047849 about?
NCT04047849 is a clinical study titled "Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA". This study is a non-blinded, prospective, randomized controlled trial designed to compare the effect of outpatient oral antibiotics (i.e., amoxicillin and azithromycin) on the length of time (days) that pregnancy continues after a patient's water bag has ruptured prematurely. If a patient has been d...
What is the current status of trial NCT04047849?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2019-08-28. Estimated completion is 2021-07-01.
What conditions does trial NCT04047849 study?
This clinical trial studies the following conditions: Preterm Birth, Preterm Labor, Preterm PROM (Pregnancy), Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture), Rupture of Membranes; Premature.
What interventions are being tested in trial NCT04047849?
The interventions under investigation include: Antibiotics, oral Azithromycin and oral Amoxicillin (DRUG).
Who is sponsoring clinical trial NCT04047849?
This trial is sponsored by Woman's, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04047849 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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