Prospective Evaluation of Pathways for Preterm Birth

Preterm Birth Clinical Trial

— PEPP  

Official title:

Prospective Evaluation of Pathways for Preterm Birth: The PEPP Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246579
• Other study ID #: 73519
• Status: Recruiting
• 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
• 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:

Patients will be approached for potential enrollment at the time of their anatomy ultrasound 18+0 and 23+6 weeks' gestation pending their obstetric history or if a transabdominal ultrasound evaluation or past transvaginal examination suggests the cervical length is less than 30 mm. Exclusion criteria will be reviewed and if none are present and the patient is considered a candidate for enrollment, informed consent will be performed. A 10-ml serum sample obtained. Before the transvaginal ultrasound, the patient will be asked to undergo a cervical washing of 3 cc of normal saline to obtain inflammatory cells followed by placement of a swab into the posterior fornix for 30 seconds. Patients who are found to have a short cervix will be prescribed standard of care medication (progesterone). Standard practice at our institution is to perform a cervical cerclage for women with a history of spontaneous preterm birth and a cervical length of =25mm at 16+0-23+6 weeks' gestation and this intervention will be continued regardless of enrollment. In addition, it is our standard to perform a cervical cerclage in women with progressive cervical change reaching a cervical length of <10 mm prior to 24+0 weeks regardless of obstetrical history. These standard practices will continue regardless of study participation. Follow-Up Testing Visits. Additional study interventions will be collection of biomarker specimens and biophysical data. At 28 and 34 weeks gestation, the patient will undergo repeat TVU and 10-ml serum sample collection. A CRF will record the cervical length and the sonographer will be blinded to any prior cervical length measurement. A different sonographer will be utilized from the immediately preceding exam. All sonographers will complete the coursework for assessment of cervical length from either the Perinatal Quality Foundation CLEAR program or the Fetal Medicine Foundation.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cervix; Pregnancy
• Premature Birth
• Preterm Birth

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