Prospective Evaluation of Pathways for Preterm Birth

Recruiting now

Conditions studied: Preterm Birth, Cervix; Pregnancy

In brief

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.

Key facts

Study ID

NCT05246579

Run by

John O'Brien, MD

People needed

240

Starts

2022-02-04

Expected to finish

2027-07-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Maternal age from 18 to 45 years of age.
• Singleton gestation.

You may not qualify if…

• 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.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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