No registrations found.
ID
Source
Brief title
Health condition
Women with uncomplicated, singleton pregnancies between 28 and 34 weeks of gestational age.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of participants with successful BOLD MRI. The study will be considered feasible when at least 78% of participants have an analysable BOLD signal, defined as a change in signal intensity with a p<0.05 between different stages of oxygenation.
Secondary outcome
None
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
01-09-2019
Intervention
Not applicable (Observational study with invasive measurement).
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
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7900 |
| CCMO | NL65570.000.18 |
| OMON | NL-OMON48878 |