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Observational Study on Preterm Birth Pathways

This study is looking at pregnant patients who are at a higher risk of having a preterm birth (when a baby is born too early). This includes those who have had a preterm birth before, have a short cervix, or are showing symptoms of preterm birth. We are also including a group of women who are pregnant for the first time and do not have a short cervix to compare. The main goal is to understand the body's inflammatory response by measuring specific markers (inflammatory cytokine profile) at different stages of pregnancy (18-24 weeks, 28 weeks, and 34 weeks). We plan to enroll 240 women between 18 and 45 years old who are pregnant with one baby. You cannot join if you've recently used certain vaginal or intramuscular progesterone treatments, or have certain heart, kidney, or uncontrolled diabetes conditions.

Study design
This is an observational study, meaning no specific treatments are given as part of the study. It aims to enroll 240 participants across different risk groups for preterm birth.
What's involved
You would have a blood sample taken and a cervical washing and swab performed. These procedures happen around 18-24 weeks of pregnancy, with follow-up measurements at 28 and 34 weeks.
Compensation
Not stated in the trial record.
Follow-up
Measurements of inflammatory cytokine profiles will be taken at 18-24 weeks, 28 weeks, and 34 weeks gestation.

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NCT05246579

Prospective Evaluation of Pathways for Preterm Birth

Recruiting
Not specifiedAges 18–45Observational
John O'Brien, MD
~240 participants
Updated 2026-08-04 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Inflammatory Cytokine Profile
Measured over 18-24 weeks gestation
+2 more outcomes measured

Conditions

Preterm Birth
Cervix; Pregnancy

Explore related trials

Preterm Birth

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

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

Who to contact

Cynthia Cockerham
[email protected]
859-629-2015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Inflammatory Cytokine Profile18-24 weeks gestation

    Serum and Cervicovaginal cytokine profile (CRP, ICAM-1, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFα, TNFβ)

  • Inflammatory Cytokine Profile28 weeks gestation

    Serum and Cervicovaginal cytokine profile (CRP, ICAM-1, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFα, TNFβ)

  • Inflammatory Cytokine Profile34 weeks gestation

    Serum and Cervicovaginal cytokine profile (CRP, ICAM-1, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFα, TNFβ)