NCT02037334

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,002

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

8.7 years

First QC Date

January 13, 2014

Last Update Submit

December 8, 2022

Conditions

Preterm Delivery

Keywords

Preterm deliveryDiagnosticsBiomechanics

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Pregnancy

Device: Pregnolia System

Interventions

Pregnolia SystemDEVICE

No intervention is done except for measuring the stiffness of the cervix in pregnant women

Pregnancy

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University Hospital of Leuven

Leuven, 3000, Belgium

Location

Kantonsspital Aarau, Frauenklinik

Aarau, Switzerland

Location

Kantonsspital Baden, Frauenklinik

Baden, Switzerland

Location

Universitätsspital Basel, Frauenklinik

Basel, Switzerland

Location

Kantonsspital Frauenfeld, Frauenklinik

Frauenfeld, Switzerland

Location

Hôpitaux universitaires de Genève (HUG)

Geneva, Switzerland

Location

Kantonsspital Luzern, Frauenklinik

Lucerne, Switzerland

Location

Kantonsspital Münsterlingen

Münsterlingen, Switzerland

Location

Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe

Sankt Gallen, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Switzerland

Location

Praxis Zollikon

Zollikon, Switzerland

Location

University Hospital of Zurich, Dept. OB/Gyn

Zurich, 8091, Switzerland

Location

Stadtspital Triemli, Frauenklinik

Zurich, Switzerland

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • David A Scheiner, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

April 1, 2014

Primary Completion

December 8, 2022

Study Completion

December 8, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Locations

CH(12)BE(1)