Status:
RECRUITING
Prospective Evaluation of Pathways for Preterm Birth
Lead Sponsor:
John O'Brien, MD
Conditions:
Preterm Birth
Cervix; Pregnancy
Eligibility:
FEMALE
18-45 years
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 an...
Detailed Description
Patients will be approached for potential enrollment at the time of their anatomy ultrasound 18+0 and 23+6 weeks' gestation pending their obstetric history or if a transabdominal ultrasound evaluation...
Eligibility Criteria
Inclusion
- Maternal age from 18 to 45 years of age.
- Singleton gestation.
Exclusion
- 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.
Key Trial Info
Start Date :
February 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05246579
Start Date
February 4 2022
End Date
June 1 2026
Last Update
July 2 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40506