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.
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: June 2021
- Device: Pregnolia
- The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.
Arms, Groups and Cohorts
- Control group
- Pregnant patients between 12w0d and 22w0d who present for prenatal care.
- Cerclage group A
- Patients who present for a history-indicated cerclage placement.
- Cerclage group B
- Patients who present for an ultrasound-indicated cerclage placement.
- Cerclage group C
- Patients who present for an exam-indicated cerclage placement.
Clinical Trial Outcome Measures
- Cervical stiffness (Pcl)
- Time Frame: 5 minutes
- The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls.
- Delivery data
- Time Frame: up to 10 months
- Patient delivery data including gestational age, mode of delivery and complications will be recorded
- Newborn outcomes
- Time Frame: up to 10 months
- Newborn outcomes including weight, APGARs and complications will be recorded
Participating in This Clinical Trial
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
1. Multiple gestation pregnancy.
2. Pregnancy complications: Premature rupture of membranes, Placental abruption, Placenta previa/accreta.
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
Gender Eligibility: Female
Patients need to be pregnant.
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Tufts Medical Center
- Provider of Information About this Clinical Study
- Overall Official(s)
- Michael House, MD, Principal Investigator, Tufts Medical Center
- Overall Contact(s)
- House Michael, MD, 617-636-3200, firstname.lastname@example.org
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