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Cervical Stiffness Measurement

Title Cervical Stiffness Measurement in Cervical Insufficiency
Therapeutic Area Cervix Disorders, Pregnancy
Principal Investigator Michael House, MD
Min Age 18 Years
Gender Female
Contact Michael House, MD


The purpose of the study is to measure the softness of the cervix.  The softness of the cervix will be compared in two groups of pregnant women.  One group is women who will be having a surgery to strengthen the cervix (a cerclage surgery).  The second group is normal women in the prenatal clinic.  We anticipate recruiting 140 patients total (60 cases and 80 control patients.)

Study Details

Inclusion Criteria

  • Pregnant Women over 18 years of age
  • Singleton pregnancy
  • Gestational age between 12w0d and 22w6d

Exclusion Criteria

  • History of cervical surgery
  • Pregnancy complications: Premature rupture of membranes, placental abruption, placenta previa
  • Infections: uterine infection, active genital infection, known HIV, hepatitis B or C

Study Requirements

The study involves a one-time cervical stiffness measurement performed using the Pregnolia probe (less than 5 minutes) and a follow-up chart review for delivery data.   There are no blood collections or imaging in this study.