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

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27604

Enrollment

520

Registered

2017-11-30

Start date

2016-05-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

English: Uteroplacental vascularization, placenta-related pregnancy complications, pregnancy outcome Dutch: Uteroplacentaire vascularisatie, placenta-gerelateerde zwangerschapscomplicaties, zwangerschapsuitkomsten

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1) Women aged between 18 years or older and 45 years or below, planning a pregnancy or < 10 weeks pregnant. 2) Understanding of Dutch language in speaking and reading.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1) Women unable or unwilling to give informed consent.

Design outcomes

Primary

Measure	Time frame
Intra- and inter-observer agreement of the measurement of the indices of placental vascularization (primary). The indices measured are the following: oPreconception uterine vascular bed: - Volume of endometrial vasculature (VEV) - Total volume of vasculature (TVV) - Uterine artery (left and right) pulsatility and resistance oPlacental vascularization (in pregnancy): - Placental Bed vasculature Volume (PVBV) - Fetal vascular volume (FVV) - Total volume of vasculature (TVV) - Uterine artery (left and right) pulsatility and resistance indices	—

Measure

Time frame

Intra- and inter-observer agreement of the measurement of the indices of placental vascularization (primary). The indices measured are the following: oPreconception uterine vascular bed: - Volume of endometrial vasculature (VEV) - Total volume of vasculature (TVV) - Uterine artery (left and right) pulsatility and resistance oPlacental vascularization (in pregnancy): - Placental Bed vasculature Volume (PVBV) - Fetal vascular volume (FVV) - Total volume of vasculature (TVV) - Uterine artery (left and right) pulsatility and resistance indices

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Secondary

Measure	Time frame
The relationship between the indices of the uteroplacental vascular volumes: a) Maternal biomarkers (blood) b) (Pre)clinical outcomes (embryonic and fetal health, 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 used).	—

Measure

Time frame

The relationship between the indices of the uteroplacental vascular volumes: a) Maternal biomarkers (blood) b) (Pre)clinical outcomes (embryonic and fetal health, 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 used).

—

Contacts

Public ContactR.P.M. Steegers -Theunissen

Erasmus MC Room Ee-2271a P.O. Box 2040

r.steegers@erasmusmc.nl+31-(0)10-703 37 60

Outcome results