To establish benchmark values in healthy control fetuses, to compare these with our cohort of fetuses with severe CHD.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Congenital and peripartum neurological conditions
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. brain age of healthy control fetuses (a combined parameter of stages of
development and cortical folding in the brain);
2. brain perfusion of healthy control fetuses;
3. brain volume of healthy control fetuses.
Secondary outcome
1. the development of biometric parameters in healthy control fetuses;
2. the timing of deviation of the aforementioned variables (if they occur, at
what gestational age do abnormalities occur during pregnancy);
3. comparison of early postnatal outcome with prenatal characteristics in
healthy control fetuses.
Background summary
Congenital heart disease (CHD) is the most prevalent congenital anomaly and
accounts for significant (neonatal) mortality and morbidity. Not only
cardiovascular and surgical problems can arise, also a high percentage of CHD
children suffer from neurodevelopmental disorders. The etiology hereof is
considered multifactorial, mainly regarding timing and type of surgery. Recent
studies have indicated that some of these neurodevelopmental disorders can
already be present at birth, even before birth. This has prompted the LUMC to
change follow up policy of fetuses with CHD, not only monitoring the fetal
heart development but also monitoring neurodevelopment. The precise
intrauterine and postpartum (perioperative) pathophysiology is however not
known. To examine the detailed characteristics of neurodevelopment it is
important to compare the findings with healthy control fetuses. This protocol
aims to include a control group to the detailed neurosonography (performed in
fetuses with CHD).
Study objective
To establish benchmark values in healthy control fetuses, to compare these with
our cohort of fetuses with severe CHD.
Study design
This study is a single-center prospective observational cohort study of
pregnant women carrying a healthy fetus, and their subsequent children.
In the normal pregnancy, ultrasonography is routinely offered at 20 weeks of GA
(structural ultrasound; *SEO*). In our study group, healthy controls will be
included for additional detailed ultrasound evaluation of brain development
(neurosonography) every 4 weeks,(at GA 20, 24, 28, 32 and 36) and a cranial
ultrasound 2-3 days after birth (this is the same follow-up schedule as fetuses
with severe CHD undergo routinely).
Study burden and risks
Ultrasound examination in pregnancy and in early neonatal life has been
performed for many years and until now no adverse effects have been found.
The fetus and /or the parents can possibly benefit from this study:
- The extra ultrasounds can confirm normal fetal development and reassure the
parents;
- The ultrasounds can detect any abnormalities in the growth and/or development
of the fetus. For example intra uterine growth retardation is an important risk
factor for adverse perinatal outcome and early detection can improve outcome.
The detailed investigation of brain parameters will not directly benefit the
fetus and/ or mother.
The results of this study will possibly benefit other fetuses /children and
their families by creating local knowledge and know-how
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, women must have a continuing singleton pregnancy of a congenitally normal fetus.
Exclusion criteria
A potential case or control who meets any of the following criteria will be excluded from participation in this study:
- Failure to obtain informed consent
- Maternal age below 18 years;
- Presence of fetal structural anomalies;
- High risk for congenital anomalies.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48266.058.14 |