|- candidate number||28274|
|- NTR Number||NTR6854|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-nov-2017|
|- Secondary IDs||2015-494 MEC |
|- Public Title||Development of a new 3D virtual desktop imaging technique for real time non-invasive evaluation of the utero-placental interface vascularization throughout pregnancy (VIRTUAL). |
|- Scientific Title||Development of a new 3D virtual desktop imaging technique for real time non-invasive evaluation of the utero-placental interface vascularization throughout pregnancy (VIRTUAL). |
|- hypothesis||Three-dimensional power Doppler ultrasound and Virtual Reality can reflect the uteroplacental circulation in an accurate and reliable way. Therefore, these measurements could serve as a marker for uteroplacental health before and throughout pregnancy. |
|- Healt Condition(s) or Problem(s) studied||Pregnancy outcome, Placenta-related pregnancy complications, Uteroplacental vascularization|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-mei-2016|
|- planned closingdate||1-okt-2019|
|- Target number of participants||520|
|- Interventions||Not applicable|
|- Primary outcome||Intra- and inter-observer agreement of the measurement of the indices of placental vascularization (primary).|
The indices measured are the following:
o Preconception uterine vascular bed:
- Volume of endometrial vasculature (VEV)
- Total volume of vasculature (TVV)
- Uterine artery (left and right) pulsatility and resistance
o Placental 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
|- Secondary outcome||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).
|- Timepoints||Study visits are scheduled preconceptionally (one visit) and in pregnancy (maximum of 6 visits, i.e. at 7, 9, 11, 13, 22 and 32 weeks of gestation). |
|- Trial web site||Not applicable|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. R.P.M. Steegers -Theunissen |
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. R.P.M. Steegers -Theunissen |
|- Sponsor/Initiator ||Erasmus University Medical Center|
(Source(s) of Monetary or Material Support)
|Erasmus University Medical Center Rotterdam, the Netherlands|
|- Publications||IF Reijnders, AGMGJ Mulders, MPH Koster, AHJ Koning, A Frudiger, SP Willemsen, E Jauniaux, GJ Burton, RPM Steegers-Theunissen, EAP Steegers. New imaging markers for preconceptional and first-trimester utero-placental vascularization. Accepted, Placenta, October 2017.|
|- Brief summary||Rationale: Early placental development plays a critical role in human reproduction. Several periconceptional environmental influences, in particular maternal lifestyle, interact with placental development and functioning, and are also related to preconceptional (sub)endometrial and uterine vascularization. Impaired development of the placental vascular bed is related to adverse pregnancy outcomes, but is also associated with maternal and child health during the life course. |
Hence, knowledge on placental (vascular) development during the periconception period needs to be expanded preferably using patient-friendly, non-invasive and safe technology that can be applied throughout pregnancy. We hypothesize that three-dimensional (3D) power Doppler ultrasound can reflect early placental vascular development, by visualization of the placental vascularization. The acquired 3D vascular volumes can be assessed using Virtual Reality systems, to enable actual depth perception and interaction between the volume and the observer.
Objectives: In this study we will investigate associations between maternal lifestyle and uterine and placental indices throughout pregnancy, obtained by the non-invasive technology (i.e. VIRTUAL clinical prototype). If patients at risk for adverse pregnancy outcomes can be identified as early as the periconception period, preventive lifestyle interventions could be applied to enable a healthy placental environment thereby optimizing the health of mothers and their offspring.
To accomplish this we have stated the following objectives:
1) To validate the reliability and applicability of regular use of the VIRTUAL (pre)clinical prototype in a bed-side setting (desktop) preconceptional and across pregnancy.
2) To investigate the development of the uterine- and utero-placental circulation and intra-placental vascularization of the preconception non-pregnant uterus and the placenta across pregnancy.
3) To test the VIRTUAL clinical prototype by investigating the preconception uterine vascular bed and indices of placental vascularization across pregnancy in relation to:
a) Maternal biomarkers in blood.
b) (Pre)clinical outcomes (embryonic and fetal health, miscarriage, preeclampsia, gestational age at delivery, and birth weight).
c) Maternal conditions and lifestyle (medication, intoxications, infections, physical activity, working activities, body mass index (BMI), blood pressure, nutrition, smoking, alcohol and folic acid supplement use).
|- Main changes (audit trail)|
|- RECORD||30-nov-2017 - 12-dec-2017|