The primary objective is feasibility of performing BOLD MRI of the placenta in our centre.
ID
Source
Brief title
Condition
- Placental, amniotic and cavity disorders (excl haemorrhages)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of participants with successful BOLD MRI.
Secondary outcome
Not applicable.
Background summary
The placenta is an essential regulatory organ that provides the fetus with
nutrients and oxygen. Optimal placenta function is crucial for fetal health and
subsequent neonatal outcome. Insufficient development of the placenta can lead
to serious pregnancy complications, such as fetal growth restriction (FGR),
increasing the risk of short and long term health consequences. Early prenatal
detection of high risk fetuses and intensive monitoring could minimize these
risks.
In the current clinical setting the gold standard for the detection and
monitoring of FGR is ultrasound biometry combined with Doppler parameters.
However, ultrasound examination predicts fetal outcome through an indirect
estimate of placental function, and has limited value for identifying impaired
placental development.
Functional Magnetic Resonance Imaging (fMRI) is a promising, non-invasive
technique for a more direct assessment of placental function. Blood Oxygen
Level-Dependent (BOLD) MRI is an fMRI technique that measures changes in tissue
oxygenation during different states of oxygenation. By analysing these changes,
placental function can be assessed. This technique could present an additional
diagnostic tool which identifies fetuses at risk for FGR. Additionally, this
technique could differentiate between FGR and constitutionally small fetuses.
Study objective
The primary objective is feasibility of performing BOLD MRI of the placenta in
our centre.
Study design
Observational study with invasive measurement.
Intervention
Oxygen supply.
Study burden and risks
MRI is safe in pregnancy. No intravenous contrast agent will be used. No
negative effects on fetal outcome have been described for short-term maternal
oxygen therapy.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Singleton, uncomplicated pregnancy between 28 and 34 weeks of gestation
- Understanding of Dutch in speaking and reading
- Signed informed consent (willingness to participate in the study)
- Minimal age of 18 years
Exclusion criteria
- Unknown or uncertain gestational age
- Congenital anomalies detected by ultrasound
- Multiple pregnancy
- (Gestational) diabetes
- Preeclampsia or fetal growth restriction
- Claustrophobia (because of the necessity to be in an MRI chamber)
- Inability to give informed consent (e.g. mentally impaired)
- Women with a pacemaker, cochlear implants, neurostimulator or subcutaneous
insulin pump (contraindications for MRI).
- Not willing to be informed about incidental findings following the
performance of the MRI
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65570.000.18 |
| Other | NL7900 |
| OMON | NL-OMON28029 |