Cervical Stiffness Measurement in Cervical Insufficiency

Study 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.

Official Title
-----------------
Cervical Stiffness Measurement in Cervical Insufficiency

Conditions
-----------------
Pregnancy Related, Cervical Insufficiency, Preterm Birth

Intervention / Treatment
-----------------
* Device: Pregnolia


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Pregnant patients between 12w0d and 22w0d who present for prenatal care. | Device: Pregnolia<br>* The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.<br>|
| Cerclage group A<br>Patients who present for a history-indicated cerclage placement. | Device: Pregnolia<br>* The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.<br>|
| Cerclage group B<br>Patients who present for an ultrasound-indicated cerclage placement. | Device: Pregnolia<br>* The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.<br>|
| Cerclage group C<br>Patients who present for an exam-indicated cerclage placement. | Device: Pregnolia<br>* The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical stiffness (Pcl) | The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery data | Patient delivery data including gestational age, mode of delivery and complications will be recorded | up to 10 months | 
| Newborn outcomes | Newborn outcomes including weight, APGARs and complications will be recorded | up to 10 months |