Cervical Stiffness Measurement in Cervical Insufficiency

September 18, 2022 updated by: Tufts Medical Center

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02122
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

We are studying pregnant patients between 12w0d and 22w6d.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Pregnant patients between 12w0d and 22w0d who present for prenatal care.
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.
Cerclage group A
Patients who present for a history-indicated cerclage placement.
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.
Cerclage group B
Patients who present for an ultrasound-indicated cerclage placement.
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.
Cerclage group C
Patients who present for an exam-indicated cerclage placement.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical stiffness (Pcl)
Time Frame: 5 minutes
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
Time Frame: up to 10 months
Patient delivery data including gestational age, mode of delivery and complications will be recorded
up to 10 months
Newborn outcomes
Time Frame: up to 10 months
Newborn outcomes including weight, APGARs and complications will be recorded
up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

Pregnolia AG

Investigators

  • Principal Investigator: Michael House, MD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2020

Primary Completion (ACTUAL)

June 15, 2022

Study Completion (ACTUAL)

June 15, 2022

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (ACTUAL)

November 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 18, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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