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Prospective Evaluation of Pathways for Preterm Birth

Prospective Evaluation of Pathways for Preterm Birth: The PEPP Study

Who can join

Ages 18 to 45 · Women · Healthy volunteers welcome

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.

About the 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.

Sponsor: John O'Brien, MD · Participants: 240 · Started: Feb 4, 2022

Contact the study team

• Cynthia Cockerham · Phone: 859-629-2015

Official record on ClinicalTrials.gov — NCT05246579

Locations in the U.S.

Conditions

• Premature Birth

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.