Studies

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Clinical Studies

Overview of studies on the development of risk profiles for spontaneous preterm birth.

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 Fundamental studies

Authors: Sabrina Badir et al.
Location: University Hospital, Zurich

Characterization of cervical stiffness in 100 healthy women using the aspiration technique to quantitatively describe the evolution of cervical stiffness in normal pregnancy.


Status: Completed, published

Authors: Sabrina Badir et al.
Location: Switzerland

Conclusion:The Pregnolia System is more reliable in assessing cervical stiffness than digital palpation.


 


Status: Completed, published

 

Authors: Sabrina Badir et al.
Location: University Hospital, Zurich

Objective determination of cervical stiffness after administration of misoprostol during insertion of an intrauterine contraceptive.
 


Status: Completed, published

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Intra-Observer – CH
Q1 2022 – Q4 2023

Investigator: Dr.med.G.Hebisch
Location: Frauenfeld Canton Hospital

Determining the intra-observer variability of a measuring device that is able to measure and quantify cervical stiffness.
 




Status: Ongoing
Status: October 2022

SoftCervix – CH
Q2 2014 – Q4 2022

Investigator: PD Dr.med.D.Scheiner et al.
Location: mult-centric, CH & BE

The study aims to demonstrate that cervical stiffness measurements might
complement cervical length data to improve prediction of preterm delivery.
Cervical stiffness with the Pregnolia System is measured at mid-pregnancy.

Status: Recruitment completed
Status: October 2022

Asymptomatic pregnant women
without risk factors

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Asymptomatic pregnant women
with risk factors

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TUFTS – USA

Q1 2020 – Q4 2022

Investigator: Dr.med.Michael House et al.
Location: Tufts Medical Center, Boston

Cervical stiffness measurement in cervical insufficiency: will women with an indicated cerclage have cervical stiffness lower than normal controls?

 

 


Status: Interim results published
Status: October 2022

Hamburg – DE

Q4 2021 – Q1 2023

Investigator: Prof.I.Kyvernitakis et al.
Location: Asklepios Barmbek, Hamburg

Impact of a pessary treatment on cervical stiffness measured by a novel aspiration
technique-based device in patients at risk for preterm birth with cervical shortening.


Status: Ongoing
Status: October 2022

ATOPS – USA

Q2 2017 – Q4 2022

Investigator: Prof.K.Myers et al.
Location: Columbia University, New York

Cervical stiffness is measured in high risk women with and without a cervical pessary. The measurement is accompanied by ultrasound imaging and the stiffness and geometric information is used together for computer modeling of the mechanical environment of each pregnancy.
Status: Recruitment completed
Status: October 2022

SPRUCE – UK

Q3 2022 – Q3 2024

Investigator: Dr.med.A.Scharp et al.
Location: Women's Hospital, Liverpool

Assessment of the vaginal microbiome in multiple pregnancies and collecting blood samples and cervical stiffness

measurements for future exploratory analysis, ultimately aiming to develop a successful sPTB risk stratification model for multiple pregnancies.

Status: Ongoing
Status: October 2022

STIPP-A – NL

Q3 2022 – Q3 2024

Investigator: Dr.med.M.Oudijk et al.
Location: Amsterdam UMC

Single centre cohort study with asymptomatic pregnant women with a history of spontaneous preterm birth before 34 weeks of gestation.
The aim of this study is to evaluate the predictive capacity of cervical softening and risk of spontaneous preterm birth.


Status: Ongoing
Status: October 2022

INSIGHT – UK

Q1 2022 – Q4 2023

Investigator: Prof.A.Shennan et al.
Location: King's College, London

A prospective cohort study to determine the biological mechanisms underlying cervical shortening and spontaneous preterm birth and identify novel biomarkers which could identify women at high risk for pre-term birth early in their pregnancy.

 


Status: Ongoing
Status: October 2022

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Symptomatic pregnant women

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Naples – IT

Q2 2022 – Q4 2022

Investigator: Dr.med.G.Saccone et al.
Location: Federico II University, Naples

Evaluate if cervical stiffness can differentiate between true/false preterm labour and if the knowledge of cervical stiffness improves the detection of women at risk of spontaneous preterm birth in combination or over state of the art.

Status: Ongoing
Status: October 2022

PBS–I – CH

Q3 2020 – Q4 2023

Investigator: Prof.D.Surbek et al.
Location: Inselspital, Bern

Pregnolia Bern Study I: Assessment of the efficacy of the cervical stiffness measurement in pregnant women
(24-33 6/7 weeks) 
with clinically intact membranes presenting with signs and symptoms of preterm labor in predicting time-to-delivery.


Status: Ongoing
Status: October 2022

STIPP-S – NL

Q3 2022 – Q4 2024

Investigator: Dr.med.M.Oudijk et al.
Location: Amsterdam UMC

Single centre cohort study with symptomatic pregnant women presenting with threatened preterm birth between 24 and 34 weeks. The aim of this study is to evaluate the predictive capacity of cervical softening and risk of spontaneous preterm birth.

Status: Ongoing
Status: October 2022

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Induction of labour

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Predict – CH

Q1 2022 – Q1 2023

Investigator: Dr.med.F.Migliorelli et al.
Location: University Hospital, Geneva

The study intends to develop a predictive model of spontaneous onset of labor
between 39 and 41 weeks of pregnancy in women carrying singletons and without indication of delivery before this date.




Status: Ongoing
Status: October 2022

PBS–II – CH

Q3 2020 – Q2 2023

Investigator: Prof.D.Surbek et al.
Location: Insel Hospital, Bern

Pregnolia Bern Study II: Assessment of the efficacy of the cervical stiffness measurements in pregnant women (37-41 6/7 weeks) attempting vaginal birth after cesarean and undergoing induction of labour.


Status: Interim results published
Status: October 2022