Biomechanics Based Prediction of Preterm Delivery | NCT02037334

Studies
Biomechanics Based Prediction of Preterm Delivery

NCT02037334

Sponsor

David Scheiner

Status

Completed

Last Update Posted

Dec 9, 2022Actual

Enrollment

1,002Actual

Phase

Not provided

Conditions

Preterm Delivery

Interventions

Pregnolia System

Countries

Belgium
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-MD-0036	Other Identifier	Swissmedic

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014Actual

Primary Completion Date

Dec 8, 2022Actual

Completion Date

Dec 8, 2022Actual

First Submitted Date

Jan 13, 2014

First Submission Date that Met QC Criteria

Jan 14, 2014

First Posted Date

Jan 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2022

Last Update Posted Date

Dec 9, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Scheiner, Sponsor-Investigator, University of ZurichSponsor-Investigator

Lead Sponsor

David ScheinerOTHER

Collaborators

Name	Class
Universitaire Ziekenhuizen KU Leuven	OTHER
Swiss Federal Institute of Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy will be compared between women with term vs. preterm delivery. We aim to demonstrate that biomechanical data (ASP and CCI) might complement morphological data (CL) to improve prediction of preterm delivery. It is expected that women with preterm delivery will show stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical consistency index) measurements are performed at mid-pregnancy: detection at this time point is useful for therapy and biomechanical modifications are already significant so to enable differentiation by biomechanical measurements (ASP and CCI).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,002Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnancy			Device: Pregnolia System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregnolia System	Device	No intervention is done except for measuring the stiffness of the cervix in pregnant women	Pregnancy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in cervical stiffness in women with/without preterm delivery	The biomechanical measurements and morphological data obtained at mid-pregnancy are compared between women with/without preterm delivery and are expected to significantly differ. The diagnostic power for preterm delivery of aspiration, CCI and the other factors will be determined.	Measurements between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All pregnant women presenting at their mid pregnancy consultation (18+0 - 22+0 weeks of pregnancy) are eligible
Signed informed consent after being informed is a prerequisite for enrollment.

Exclusion Criteria:

Communication problems
Missing consent
Age<18
Active bleeding / Premature Rupture of Membranes (PROM)
Active genital infection
Known carrier of HIV or Hepatitis B or C
Placenta praevia
Müllerian anomalies
known or suspected non-compliance, drug or alcohol abuse
cerclage
use of pessary

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

All pregnant women at our institutions between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David A Scheiner, MD	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Leuven		Leuven		3000	Belgium
Kantonsspital Aarau, Frauenklinik

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

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