Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
NCT ID: NCT04294069
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
6 participants
INTERVENTIONAL
2020-09-14
2021-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Azithromycin Versus Erythromycin For Preterm Prelabor Rupture of Membranes
NCT05328817
Azithromycin for Preterm Pre-labor Rupture of Membranes
NCT04202380
Azithromycin Before Induction
NCT06543290
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
NCT06605118
Azithromycin for Preventing Maternal and Neonatal Infections During Labor.
NCT06958146
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Azithromycin 500mg
500mg azithromycin PO daily for seven days
Azithromycin 500 mg
500mg azithromycin PO for seven days starting on admission
Azithromycin 1000mg
1000mg azithromycin PO once at admission
Azithromycin Oral Product
1000mg azithromycin PO once at admission
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Azithromycin 500 mg
500mg azithromycin PO for seven days starting on admission
Azithromycin Oral Product
1000mg azithromycin PO once at admission
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosed with preterm premature rupture of membranes:
* History consistent with ruptured membranes (ie leaking, gush of fluid)
* Sterile speculum exam with pooling
* Fluid positive for ferning and/or nitrazine
* With or without confirmatory test such as Amnisure
Exclusion Criteria
* Active labor, abruption, chorioamnionitis at enrollment
* Other contraindication to expectant management of PPROM at enrollment
14 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Christiana Care Health Services
OTHER
Thomas Jefferson University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rupsa C Boelig, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20G.119
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.