Evaluation of pathways for preventing preterm birth
Prospective Evaluation of Pathways for Preterm Birth: The PEPP Study
This study is trying to find ways to prevent preterm birth in pregnant women who are at high risk, while also comparing them to women who are not at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05246579 on ClinicalTrials.gov |
What this trial studies
This observational study involves a prospective cohort of pregnant patients at high risk for spontaneous preterm birth, including those with a history of preterm birth, a short cervix, or symptoms indicative of preterm labor. A control group of nulliparous patients without a short cervix will also be included to provide baseline data. The study aims to enroll 240 patients, with 60 in each group, and will collect serum samples and inflammatory cell data through cervical washing. Standard care interventions, such as progesterone treatment and cervical cerclage, will be maintained regardless of study participation.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 to 45 with singleton gestations who are at high risk for spontaneous preterm birth.
Not a fit: Patients with major fetal anomalies, significant uterine malformations, or those currently receiving progesterone treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding and management of preterm birth risk, potentially leading to better outcomes for at-risk pregnancies.
How similar studies have performed: While this study builds on existing knowledge of preterm birth risk factors, its specific approach and methodology may provide novel insights into prevention strategies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: John O'Brien, MD — University of Kentucky
- Study coordinator: Cynthia Cockerham
- Email: cynthia.cockerham@uky.edu
- Phone: 859-629-2015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.