Prospective Evaluation of Pathways for Preterm Birth

NCT05246579 | Recruiting

• 1 other identifier: 73519
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Cervical Length; Preterm Birth; Inflammation

Outcome Measures

Primary Outcomes (3)

• Inflammatory Cytokine Profile

  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)

  18-24 weeks gestation

• Inflammatory Cytokine Profile

  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)

  28 weeks gestation

• Inflammatory Cytokine Profile

  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)

  34 weeks gestation

Secondary Outcomes (3)

• Progesterone Cytokine Response

  18-24 weeks gestation

• Progesterone Cytokine Response

  28 weeks gestation

• Progesterone Cytokine Response

  34 weeks gestation

Study Arms (4)

Patients with short cervix

Patients with a short cervix identified on transvaginal ultrasound \<30 mm

Patients with a history of spontaneous preterm birth

Patients with a history of spontaneous preterm birth (\<34 weeks)

Patients with symptoms of preterm birth

Patients with preterm premature rupture of membranes or \</=2 cm dilated before 34 weeks gestation.

Control/Nulliparous

Nulliparous patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Subpopulation 1: Asymptomatic women with or without a history of spontaneous preterm birth who undergo screening for preterm birth with transvaginal sonography between 18-24 weeks of gestation with a cervical length =5mm and up to and including 30mm will be eligible for enrollment. * Subpopulation 2: Asymptomatic with a history of early spontaneous (PTL or PROM as etiology) occurring in a prior pregnancy at 20-34 weeks' gestation. * Subpopulation 3: Patients with symptoms of preterm birth: preterm contractions or preterm premature rupture of membranes at less than 34 weeks. * Control Subpopulation: Nulliparous women with a cervical length of \>30 mm

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• John O'Brien, MD: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Inflammation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John O'Brien, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Cockerham

CONTACT

859-629-2015; cynthia.cockerham@uky.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 18, 2022
• Study Start: February 4, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)