RECRUITING

Prospective Evaluation of Pathways for Preterm Birth

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Conditions

Preterm BirthCervix; PregnancyCervical LengthInflammation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Prospective Evaluation of Pathways for Preterm Birth: The PEPP Study

Quick Facts

Study Start:2022-02-14
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05246579

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Maternal age from 18 to 45 years of age.
  2. * Singleton gestation.
  1. * Treatment with vaginal progesterone or intramuscular progestogen within the previous 4 weeks.
  2. * 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.
  3. * Current pregnancy with a major fetal anomaly or known chromosomal abnormality.
  4. * The subject has a marked uterine anatomic malformation that may alter pregnancy duration such as a septated uterus, unicornuate uterus, or uterine didelphys.
  5. * The subject is considered not capable or unwilling to undergo study procedures and requirements.
  6. * The subject is symptomatic with vaginal bleeding at enrollment visit.

Contacts and Locations

Study Contact

Cynthia Cockerham
CONTACT
859-629-2015
cynthia.cockerham@uky.edu
Ashley Boerrigter, MD
CONTACT
859-257-2321
ashley.boerrigter@uky.edu

Principal Investigator

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 Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40506
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-14
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2022-02-14
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • Cervical Length
  • Preterm Birth
  • Inflammation

Additional Relevant MeSH Terms

  • Preterm Birth
  • Cervix; Pregnancy