Prospective Evaluation of Pathways for Preterm Birth
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorJohn O'Brien, MD
About this trial
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
Qualifiers
Maternal age from 18 to 45 years of age.
Singleton gestation.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
240 Participants
are grouped into 4 trial groupsSponsors and collaborators
John O'Brien, MD
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov