Biomechanics Based Prediction of Preterm Delivery (Softcervix)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02037334 |
Recruitment Status :
Recruiting
First Posted : January 15, 2014
Last Update Posted : April 27, 2021
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Condition or disease | Intervention/treatment |
---|---|
Preterm Delivery | Device: Pregnolia System |
Study Type : | Observational |
Estimated Enrollment : | 763 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Biomechanics Based Prediction of Preterm Delivery |
Actual Study Start Date : | April 2014 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Group/Cohort | Intervention/treatment |
---|---|
Pregnancy |
Device: Pregnolia System
No intervention is done except for measuring the stiffness of the cervix in pregnant women |
- Difference in cervical stiffness in women with/without preterm delivery [ Time Frame: Measurements between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum ]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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037334
Contact: David A Scheiner, MD | 00 41 44 255 93 08 | david.scheiner@usz.ch | |
Contact: Simone Kälin | simone.kaelin@kssg.ch |
Belgium | |
University Hospital of Leuven | Recruiting |
Leuven, Belgium, 3000 | |
Contact: Jute Richter, MD 003216340829 jute.richter@uzleuven.be | |
Principal Investigator: Jan Deprest, Prof. | |
Sub-Investigator: Jute Richter, MD | |
Sub-Investigator: Sander Galjaard | |
Sub-Investigator: Julio Jimenez | |
Switzerland | |
Kantonsspital Aarau, Frauenklinik | Recruiting |
Aarau, Switzerland | |
Contact: Monya Todesco, MD | |
Principal Investigator: Monia Tedesco | |
Kantonsspital Baden, Frauenklinik | Recruiting |
Baden, Switzerland | |
Contact: Leonard Schäffer, MD | |
Principal Investigator: Leonard Schäffer, MD | |
Universitätsspital Basel, Frauenklinik | Recruiting |
Basel, Switzerland | |
Contact: Irene Hösli, Prof. | |
Principal Investigator: Irene Hösli, Prof. | |
Kantonsspital Frauenfeld, Frauenklinik | Recruiting |
Frauenfeld, Switzerland | |
Contact: Gundula Hebisch, MD | |
Principal Investigator: Gundula Hebisch | |
Hôpitaux universitaires de Genève (HUG) | Recruiting |
Genève, Switzerland | |
Contact: Begona Martinez de Tejeda, Prof | |
Kantonsspital Luzern, Frauenklinik | Recruiting |
Luzern, Switzerland | |
Contact: Alice Winkler, MD | |
Principal Investigator: Alice Winkler, MD | |
Kantonsspital Münsterlingen | Recruiting |
Münsterlingen, Switzerland | |
Contact: Markus Kuther, MD | |
Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe | Recruiting |
St. Gallen, Switzerland | |
Contact: Tina Fischer, MD | |
Kantonsspital Winterthur | Recruiting |
Winterthur, Switzerland | |
Contact: Elke Prentl, MD | |
Praxis Zollikon | Recruiting |
Zollikon, Switzerland | |
Contact: Alexander Krafft, MD | |
University Hospital of Zurich, Dept. OB/Gyn | Recruiting |
Zurich, Switzerland, 8091 | |
Contact: David A Scheiner, MD 0041442559308 david.scheiner@usz.ch | |
Principal Investigator: Roland Zimmermann, Prof. | |
Sub-Investigator: Kathrin Rohling | |
Sub-Investigator: Katarina Quack | |
Stadtspital Triemli, Frauenklinik | Recruiting |
Zurich, Switzerland | |
Contact: Stephanie von Orelli, MD | |
Principal Investigator: Stephanie von Orelli |
Principal Investigator: | David A Scheiner, MD | University of Zurich |
Responsible Party: | David Scheiner, Sponsor-Investigator, University of Zurich |
ClinicalTrials.gov Identifier: | NCT02037334 |
Other Study ID Numbers: |
KEK-ZH 2013-0244 2013-MD-0036 ( Other Identifier: Swissmedic ) |
First Posted: | January 15, 2014 Key Record Dates |
Last Update Posted: | April 27, 2021 |
Last Verified: | April 2021 |
Preterm delivery Diagnostics Biomechanics |
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |