Prospective Evaluation of Pathways for Preterm Birth

Description

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

Preterm Birth, Cervix; Pregnancy

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Study Overview

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Study Details

Study overview

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.

Prospective Evaluation of Pathways for Preterm Birth: The PEPP Study

Prospective Evaluation of Pathways for Preterm Birth

Condition
Preterm Birth
Intervention / Treatment

-

Contacts and Locations

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Maternal age from 18 to 45 years of age.
  • * Singleton gestation.
  • * 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.

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

John O'Brien, MD,

Calvin Ward, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Ashley Boerrigter, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

John O'Brien, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

2026-06-01