Preterm Birth Clinical Trial
— PEPPOfficial title:
Prospective Evaluation of Pathways for Preterm Birth: The PEPP Study
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 |
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
John O'Brien, MD |
United States,
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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