Prospective Evaluation of Pathways for Preterm Birth
Trial Parameters
Brief 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 Criteria
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.