Preterm BirthPEPPNCT05246579
Prospective Evaluation of Pathways for Preterm Birth
An observational study of Preterm Birth and Cervix; Pregnancy, run by John O'Brien, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Cervix; Pregnancy
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2022to 1 Jul 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Maternal age from 18 to 45 years of age.
- Singleton gestation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Cynthia Cockerham, ctcock2@uky.edu
About this study
Official title: Prospective Evaluation of Pathways for Preterm Birth: The PEPP Study
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.
Read the detailed 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.
- Conditions
- Preterm Birth, Cervix; Pregnancy
- Keywords
- Cervical Length, Preterm Birth, Inflammation
- Medical subject headings
- Premature Birth, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 34 weeks gestation
Secondary outcomes (3)
Progesterone Cytokine Response
Serum and cervicovaginal cytokine profiles of those patients receiving progesterone for short cervix before and after exposure. (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)
Measured: 18-24 weeks gestation
Progesterone Cytokine Response
Serum and cervicovaginal cytokine profiles of those patients receiving progesterone for short cervix before and after exposure. (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)
Measured: 28 weeks gestation
Progesterone Cytokine Response
Serum and cervicovaginal cytokine profiles of those patients receiving progesterone for short cervix before and after exposure. (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)
Measured: 34 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start4 Feb 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John O'Brien, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John O'Brien, MD, University of Kentucky
- Investigators
- John O'Brien, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246579
- Sponsor's protocol ID
- 73519
- Acronym
- PEPP
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2022
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No