Cervical Insufficiency, Pregnancy Related, Preterm Birth
Conditions
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.
Interventions
DEVICEPregnolia
The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.
Sponsors
Pregnolia AG
Tufts Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant women over 18 years of age. 2. Singleton gestation. 3. Gestational ages between 12w0d and 22w6d. 4. Candidates for cerclage 5. Normal controls, which will be matched to cerclage subjects by gestational age and parity
Exclusion criteria
1. Multiple gestation pregnancy. 2. Pregnancy complications: Premature rupture of membranes, Placental abruption, Placenta previa/accreta. 3. Chorioamnionitis 4. Preterm contractions 5. History of cervical surgery (LEEP, trachelectomy, conization). 6. Mullarian anomaly 7. Known carrier or HIV or Hepatitis B/C 8. Active genital infection 9. Communication problems (cognitively impaired adults unable to give consent) 10. Cerclage placement already performed this pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical stiffness (Pcl) | 5 minutes | The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delivery data | up to 10 months | Patient delivery data including gestational age, mode of delivery and complications will be recorded |
| Newborn outcomes | up to 10 months | Newborn outcomes including weight, APGARs and complications will be recorded |
Countries
United States
Outcome results
None listed