Impact of Pessary Treatment on Cervical Stiffness Measurement and Birth Outcomes in Patients at Risk for Preterm Birth

NCT ID: NCT05267717

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2022-12-31

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.

Conditions

Preterm Birth

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control/Normal (no-pessary) group

All participants will 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 for a normal cohort are being enrolled only asymptomatic pregnant women with no risk factors for spontaneous preterm birth

Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical Stiffness

Intervention Type: OTHER

Non-interventional study,

Pessarry group

All participants will 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 additional cohort-specific criteria need to be met. Those are: suspected short cervix and confirmotian with transvaginal ultrasound - TVUS (CL < 3rd percentile at gestational age at measurement) according to Salomon at al.

Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical Stiffness

Intervention Type: OTHER

Non-interventional study,

Interventions

Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical Stiffness

Non-interventional study,

Intervention Type: OTHER

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

AG Pregnolia

UNKNOWN

Sponsor Role: collaborator

Asklepios proresearch

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ASKLEPIOS proresearch, Department of Pre-and Perinatal Medicine, Asklepios Barmbek, Hamburg-Barmbek, Germany.

Hamburg, Lohmühlenstraße 5/Haus J,, Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Ioanis Kyvernitakis, Prof. dr. med.

Role: primary

i.kyvernitakis@asklepios.com

+4917682487002

Other Identifiers

#4011

Identifier Type: -

Identifier Source: org_study_id