Clinical trial NCT02037334: Biomechanics Based Prediction of Preterm Delivery
Official title: Biomechanics Based Prediction of Preterm Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Delivery
Keywords: Preterm delivery
Diagnostics
Biomechanics
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: Swiss Federal Institute of Technology
First posted: 2014-01-15
Enrollment: 1002
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women at our institutions between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum

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).


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

Primary outcomes:
measure: Difference in cervical stiffness in women with/without preterm delivery
timeFrame: Measurements between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital of Leuven
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau, Frauenklinik
city: Baden
country: Switzerland
facility: Kantonsspital Baden, Frauenklinik
city: Basel
country: Switzerland
facility: Universitätsspital Basel, Frauenklinik
city: Frauenfeld
country: Switzerland
facility: Kantonsspital Frauenfeld, Frauenklinik
city: Genève
country: Switzerland
facility: Hôpitaux universitaires de Genève (HUG)
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern, Frauenklinik
city: Münsterlingen
country: Switzerland
facility: Kantonsspital Münsterlingen
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen, Klinik für Gynäkologie und Geburtshilfe
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zollikon
country: Switzerland
facility: Praxis Zollikon
city: Zurich
country: Switzerland
facility: University Hospital of Zurich, Dept. OB/Gyn
city: Zurich
country: Switzerland
facility: Stadtspital Triemli, Frauenklinik
Study officials:
affiliation: University of Zurich
name: David A Scheiner, MD
role: PRINCIPAL_INVESTIGATOR
References: