Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT05246579

Prospective Evaluation of Pathways for Preterm Birth

Led by John O'Brien, MD · Updated on 2025-07-02

240

Participants Needed

1

Research Sites

225 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prospective Evaluation of Pathways for Preterm Birth

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Maternal age from 18 to 45 years of age.
  • Singleton gestation.
Not Eligible

You will not qualify if you...

  • 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.
  • Marked uterine anatomic malformation that may alter pregnancy duration such as a septated uterus, unicornuate uterus, or uterine didelphys.
  • Considered not capable or unwilling to undergo study procedures and requirements.
  • Symptomatic with vaginal bleeding at enrollment visit.

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40506

Actively Recruiting

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Research Team

C

Cynthia Cockerham

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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