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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05246579
Other study ID # 73519
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 14, 2022
Est. completion date June 1, 2026

Study information

Verified date April 2024
Source University of Kentucky
Contact Cynthia Cockerham
Phone 859-629-2015
Email cynthia.cockerham@uky.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
John O'Brien, MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inflammatory Cytokine Profile Serum and Cervicovaginal cytokine profile (CRP, ICAM-1, IL-1a, IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFa, TNFß) 18-24 weeks gestation
Primary Inflammatory Cytokine Profile Serum and Cervicovaginal cytokine profile (CRP, ICAM-1, IL-1a, IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFa, TNFß) 28 weeks gestation
Primary Inflammatory Cytokine Profile Serum and Cervicovaginal cytokine profile (CRP, ICAM-1, IL-1a, IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFa, TNFß) 34 weeks gestation
Secondary Progesterone Cytokine Response Serum and cervicovaginal cytokine profiles of those patients receiving progesterone for short cervix before and after exposure. (CRP, ICAM-1, IL-1a, IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFa, TNFß) 18-24 weeks gestation
Secondary Progesterone Cytokine Response Serum and cervicovaginal cytokine profiles of those patients receiving progesterone for short cervix before and after exposure. (CRP, ICAM-1, IL-1a, IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFa, TNFß) 28 weeks gestation
Secondary Progesterone Cytokine Response Serum and cervicovaginal cytokine profiles of those patients receiving progesterone for short cervix before and after exposure. (CRP, ICAM-1, IL-1a, IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFa, TNFß) 34 weeks gestation
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