NCT05246579 Prospective Evaluation of Pathways for Preterm Birth
| NCT ID | NCT05246579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | John O'Brien, MD |
| Condition | Preterm Birth |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2022-02-04 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2022-02-04 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single center, prospective cohort study of pregnant patients at high risk for spontaneous preterm birth: patient's with history of spontaneous preterm birth, patient's with a short cervix and patient's symptomatic for preterm birth will be included. A control cohort of nulliparous patients without a short cervix will be recruited to provide baseline data. Plan to enroll 240 patients identified through our ultrasound unit with goal of 60 patients in each group.
Eligibility Criteria
Inclusion Criteria: * Maternal age from 18 to 45 years of age. * Singleton gestation. Exclusion Criteria: * Treatment with vaginal progesterone or intramuscular progestogen within the previous 4 weeks. * History of congestive heart failure, chronic renal failure, or uncontrolled diabetes mellitus, or diabetes mellitus with evidence of end organ dysfunction secondary to vascular disease. * Current pregnancy with a major fetal anomaly or known chromosomal abnormality. * The subject has a marked uterine anatomic malformation that may alter pregnancy duration such as a septated uterus, unicornuate uterus, or uterine didelphys. * The subject is considered not capable or unwilling to undergo study procedures and requirements. * The subject is symptomatic with vaginal bleeding at enrollment visit.
Contact & Investigator
John O'Brien, MD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT05246579 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05246579 currently recruiting?
Yes, NCT05246579 is actively recruiting participants. Contact the research team at cynthia.cockerham@uky.edu for enrollment information.
Where is the NCT05246579 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT05246579 clinical trial?
NCT05246579 is sponsored by John O'Brien, MD. The principal investigator is John O'Brien, MD at University of Kentucky. The trial plans to enroll 240 participants.