Cervical Stiffness Measurement in Cervical Insufficiency

Tufts University

Status: Completed

Conditions: Cervical Insufficiency; Pregnancy Related; Preterm Birth

Treatments: Device: Pregnolia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04158401

13549

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

136 participants in 4 patient groups

Control group

Description:

Pregnant patients between 12w0d and 22w0d who present for prenatal care.

Treatment:

Device: Pregnolia

Cerclage group A

Description:

Patients who present for a history-indicated cerclage placement.

Treatment:

Device: Pregnolia

Cerclage group B

Description:

Patients who present for an ultrasound-indicated cerclage placement.

Treatment:

Device: Pregnolia

Cerclage group C

Description:

Patients who present for an exam-indicated cerclage placement.

Treatment:

Device: Pregnolia