Prospective Evaluation of Pathways for Preterm Birth

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
John O'Brien, MD
Study ID
NCT05246579
Status
Recruiting
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Conditions

  • Cervix; Pregnancy
  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Feb 4, 2022
Status verified
Jun 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: Patients with short cervix
    Patients with a short cervix identified on transvaginal ultrasound \<30 mm
  • Arm: Patients with a history of spontaneous preterm birth
    Patients with a history of spontaneous preterm birth (\<34 weeks)
  • Arm: Patients with symptoms of preterm birth
    Patients with preterm premature rupture of membranes or \</=2 cm dilated before 34 weeks gestation.
  • Arm: Control/Nulliparous
    Nulliparous patients

Primary Outcome Measure

Inflammatory Cytokine Profile [ Time Frame: 18-24 weeks gestation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Cynthia Cockerham
[email protected]

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By research site
University of Kentucky· Lexington, KY

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