Prospective Evaluation of Pathways for Preterm Birth
Prospective Evaluation of Pathways for Preterm Birth: The PEPP Study
John O'Brien, MD
240 participants
Feb 4, 2022
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Maternal age from 18 to 45 years of age.
- Singleton gestation.
Exclusion Criteria6
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05246579