Prospective Evaluation of Pathways for Preterm Birth
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 cer
| Condition(s) | Preterm Birth, Cervix; Pregnancy |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | John O'Brien, MD |
| Locations | Lexington, Kentucky, United States |
| Start date | 2022-02-04 |
| NCT ID | NCT05246579 |
| Official listing | https://clinicaltrials.gov/study/NCT05246579 |