Preterm Birth
Conditions
Keywords
Preterm Birth, Cervical stiffness, Risk assessment, Pregnolia System
Brief summary
Background: A preterm birth remain a worldwide important socioeconomic burden since prematurity has been consistently implicated in a wide range of health medical problems affecting newborn child and contributed in up to more than a half of overall perinatal mortality. Several studies have shown a significant therapeutic benefit as a result of an antenatal cervical pessary use in a high-risk preterm birth group of pregnant women. However the underlying mechanism by which pessary can reduce a risk of a preterm birth remain elusive. The study aims to quantitatively assess an ectocervical stiffness in a normal and in a treated with a pessary high-risk preterm birth pregnancy. Methods: A prospective, non-interventional, post-market, monocentric, longitudinal, cohort study in a obstetric-led tertiary maternity teaching hospital to determine ectocervical stiffness and its changes measured prior and after the placement of a pessary, and the correlation of measured cervical stiffness or its changes with birth outcome in a high-risk preterm birth pregnant women indicated for cervical pessary. A cervical stiffness measured with Pregnolia system as the Cervical Stiffness Index (CSI, in mbar) will be a primary, whilst patient delivery data (gestational age, mode of delivery and complications) will be a secondary endpoint. In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) completed the study; Pessary cohort: 60 (up to 71 recruited), normal cohort: 60 (up to 71 recruited). Discussion: We hypothesize than the study will substantially improve our knowledge about cervical incontinency and preterm labour pathophysiology. We hope that our investigation will be able to elucidate ectocervical stiffness phenomenon both in high-risk preterm birth and in normal pregnant control, as well as the impact of cervical pessary use on a the CSI values.
Interventions
OTHERNon-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical Stiffness
Non-interventional study,
Sponsors
AG Pregnolia
Asklepios proresearch
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
All participants must meet the criteria in order to be eligible: a singleton gestation, pregnant women recruited between 18+0 - 24+6 weeks of gestation, maternal age ≥18 years, the ability to sign approved consent form to participate in the study. Moreover both for a pessary cohort and for a normal cohort additional cohort-specific criteria for each group will need to be met. For the pessary cohort those shall consist of: suspected short cervix and confirmed on TVUS (CL \< 3rd percentile at gestational age at measurement) according to Salomon at al, whilst for the control (no-pessary) group: asymptomatic pregnant women with no risk factors for spontaneous preterm birth, respectively
Exclusion criteria
Any possible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Stiffness Index | The first visit (18+0-24+6 weeks of gestation) and the follow-up visit (4 weeks later) | The primary objective is to determine the absolute value of CSI (Cervical Stiffness Index) and its change over time in women undergoing pessary treatment, in comparison to normal pregnancies, when measured at 18+0 to 24+6 weeks and at the follow-up visit (4 weeks later). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the correlation of the initial CSI and CSI changes with birth outcome | The first visit (18+0-24+6 weeks of gestation) and the follow-up visit (4 weeks later) | The secondary objective is to determine the correlation of the initial CSI and CSI changes with birth outcome (gestational age at birth). The safety objective is the safety of the device, by assessing incidence, severity and seriousness of device-related adverse events. |
Countries
Germany
Outcome results
None listed