Clinical trial NCT04158401: Cervical Stiffness Measurement in Cervical Insufficiency
Official title: Cervical Stiffness Measurement in Cervical Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Cervical Insufficiency
Preterm Birth
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Pregnolia AG
First posted: 2019-11-08
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are studying pregnant patients between 12w0d and 22w6d.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cervical stiffness (Pcl)
timeFrame: 5 minutes
Secondary outcomes:
measure: Delivery data
timeFrame: up to 10 months
measure: Newborn outcomes
timeFrame: up to 10 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Michael House, MD
role: PRINCIPAL_INVESTIGATOR
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