Cervical Stiffness Measurement in Cervical Insufficiency
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- Tufts Medical Center
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Cervical stiffness (Pcl)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The goal of this cross sectional study is to evaluate the differences in cervical stiffness between patients who present for cerclage placement versus normal pregnancies.
The central hypothesis is that women for whom a cerclage is indicated will have cervical stiffness measurements lower than normal controls. Cervical stiffness will be objectively measured by the closing pressure Pcl using the Pregnolia measurement device. This is performed during a speculum exam by placing the measurement probe on the ectocervix.
In current clinical care, there is no objective measurement of cervical stiffness. An accurate measurement of cervical stiffness that correlates with clinical outcome will advance the field. Successful completion of the current study will spark future studies that correlate cervical stiffness pcl in a prospective study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women over 18 years of age.
- •Singleton gestation.
- •Gestational ages between 12w0d and 22w6d.
- •Candidates for cerclage
- •Normal controls, which will be matched to cerclage subjects by gestational age and parity
Exclusion Criteria
- •Multiple gestation pregnancy.
- •Pregnancy complications: Premature rupture of membranes, Placental abruption, Placenta previa/accreta.
- •Chorioamnionitis
- •Preterm contractions
- •History of cervical surgery (LEEP, trachelectomy, conization).
- •Mullarian anomaly
- •Known carrier or HIV or Hepatitis B/C
- •Active genital infection
- •Communication problems (cognitively impaired adults unable to give consent)
- •Cerclage placement already performed this pregnancy
Outcomes
Primary Outcomes
Cervical stiffness (Pcl)
Time Frame: 5 minutes
The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls.
Secondary Outcomes
- Newborn outcomes(up to 10 months)
- Delivery data(up to 10 months)