Evaluation of pathways for preventing preterm birth
Official title: Prospective Evaluation of Pathways for Preterm Birth: The PEPP Study
Run by University of Kentucky · NCT05246579 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | February 4, 2022 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT05246579 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women aged 18 to 45 with singleton gestations who are at high risk for spontaneous preterm birth.
✕Probably not a fit
Patients with major fetal anomalies, significant uterine malformations, or those currently receiving progesterone treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this study builds on existing knowledge of preterm birth risk factors, its specific approach and methodology may provide novel insights into prevention strategies.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
L-citrulline supplementation during pregnancy to reduce adverse birth outcomes in Kenyan women at risk of malaria.
This trial will test whether taking a twice-daily L-citrulline supplement during pregnancy helps Kenyan women at risk of malaria have healthier pregnancies and babies.
-
Training healthcare providers on cervical exams during labor and delivery
This study is testing whether training healthcare providers with a special simulator can make cervical exams during labor more accurate and consistent for expectant mothers.
-
Pregnant Women Living with HIV on Bictegravir/Emtricitabine/Tenofovir Alafenamide
This study looks at how B/F/TAF is used in pregnant women with HIV and whether it helps maintain viral suppression from before conception through delivery.
-
Pelvic Floor Training and a Modified Lumbopelvic Belt for Symphysis Pubis Pain in Pregnancy
This study tests whether pelvic floor muscle training plus a modified lumbopelvic belt can reduce pain and improve function for pregnant women with symphysis pubis pain.
-
Effective Communication in VBAC Counseling
This study tests how clearly doctors and midwives explain VBAC options during prenatal visits and whether patients feel understood.
-
Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy
This study tests a dedicated IBD pregnancy care model, including a new virtual approach, to see if it improves access and quality of care for pregnant people with Crohn's disease or ulcerative colitis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.