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Development of a new 3D virtual desktop imaging technique for real time non-invasive evaluation of the utero-placental interface vascularization throughout pregnancy.

Development of a new 3D virtual desktop imaging technique for real time non-invasive evaluation of the utero-placental interface vascularization throughout pregnancy. - VIRTUAL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44711
Enrollment
520
Registered
2016-01-20
Start date
2016-05-12
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placental development

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Women * 18 and 45 * years of age, planning a pregnancy or

Exclusion criteria

Exclusion criteria: 1) Women unable or unwilling to give informed consent.

Design outcomes

Primary

MeasureTime frame
Part I Preclinical study using the VIRTUAL preclinical prototype Intra- and inter-observer agreement of the measurement of the indices of placental vascularization. The indices measured are the following: - Preconception uterine vascular bed: Volume of endometrial vasculature (VEV) Total volume of vasculature (TVV) Uterine artery (left and right) pulsatility and resistance - Placental vascularization: Placental Bed vasculature Volume (PVBV) Fetal vascular volume (FVV) Total volume of vasculature (TVV) Uterine artery (left and right) pulsatility and resistance Part II Clinical study using the VIRTUAL clinical prototype Indices of the preconception uterine vascular bed (PREC) and indices of placental vascularization (PREG) measured by the VIRTUAL clinical prototype. The indices measured are the following: - Preconception uterine vascular bed: Volume of endometrial vasculature (VEV) Total volume of vasculature (TVV) Uterine artery (left and right) pulsatility and resistance - Placental vascularization: Placental Bed vasculature Volume (PVBV) Foetal vascular volume (FVV) Total volume of vasculature (TVV) Uterine artery (left and right) pulsatility and resistance—

Secondary

MeasureTime frame
The relationship between the indices of the preconception uterine vascular bed (PREC) together with the indices of placental vascularization (PREG): a) Maternal biomarkers (blood) b) (Pre)clinical outcomes (embryonic and fetal (head) growth trajectories,miscarriage, preeclampsia, gestational age at delivery, and birth weight) c) Maternal conditions and lifestyle (medication use, intoxications, infections, physical activity, working activities, body mass index (BMI), blood pressure, nutrition, smoking, alcohol and folic acid supplement use)—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)