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

NCT05267717 | Unknown

• 1 other identifier: #4011
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Preterm Birth; Cervical stiffness; Risk assessment; Pregnolia System

Outcome Measures

Primary Outcomes (1)

• Cervical Stiffness Index

  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).

  The first visit (18+0-24+6 weeks of gestation) and the follow-up visit (4 weeks later)

Secondary Outcomes (1)

• 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)

Study Arms (2)

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

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

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.

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

Interventions

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

Non-interventional study,

Control/Normal (no-pessary) group; Pessarry group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: only pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study population Determining a study eligibility will occur on a first visit. Since our research will be longitudinal and cohort study, two cohorts of subjects to enable a cross group differences comparison will be distinguished: the pessary and the normal (non-pessary) cohort. Sample size calculation 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). Currently, it is difficult to perform a formal power analysis since the primarx System is a novel device and limited underlying clinical data exists.

You may qualify if:

• 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

Sponsors & Collaborators

• Asklepios proresearch: lead
• AG Pregnolia: collaborator

Study Sites (1)

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

Hamburg, Lohmühlenstraße 5/Haus J,, 20099, Germany

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 4, 2022
• Study Start: November 23, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-01

Locations

DE (1)