The primary objective of this study is: * to provide baseline normative data of the fetal face. The secondary objectives of the study are: * to compare two-dimensional ultrasound with three-dimensional ultrasound in evaluating the fetal face. * to…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Of 300 volunteers about 20 measurements of the fetal face will be taken with
two- and three-dimensional ultrasound.
Secondary outcome
A set of two MAAS-questionnaires of the volunteers participating in the study
will be collected.
Background summary
Facial anomalies are part of many syndromes and chromosomal disorders.
The prenatal recognition of a facial anomaly and the possible presents of a
genetic syndrome or chromosomal disorder can change obstetrical management and
neonatal care.
Morphological standards that describe the fetal face are very rare.
Three-dimensional ultrasound is seen as a potential new instrument to clarify
facial anatomy and consequently diagnose anomalies. Objective normative data of
the fetal face will provide standards for classification, comparison,
documentation and communication and may facilitate early diagnosis of
malformation syndromes. Ultimately this will assist the physician to provide
the parents with adequate counseling regarding prognosis, treatment options,
preventative care, pathogenesis and recurrence risk.
Study objective
The primary objective of this study is:
* to provide baseline normative data of the fetal face.
The secondary objectives of the study are:
* to compare two-dimensional ultrasound with three-dimensional ultrasound
in
evaluating the fetal face.
* to explore the effect of three-dimensional ultrasound of the fetal face
on
maternal bonding.
Study design
The study will be a prospective observational non-invasive study.
Study burden and risks
Nature and extent of the burden:
About 300 volunteers will participate one time for an abdominal ultrasound
examination of 30 minutes (transsectionally). They will be asked to fill in the
MAAS questionnaire one week before the ultrasound and two weeks after the
ultrasound. This will take about 5 minutes each time. They will also be asked
to send a return form after birth. This will take about 2 minutes.
About 30 volunteers will participate 6 times for an ultrasound examination of
about 15 minutes (longitudinallly). They will be asked to fill in the MAAS
questionnaire one week before the first ultrasound and two week after the last
ultrasound. They will also be asked to send a return form after birth.
Risks associated with participation:
There are no health risks associated with two-or three dimensional ultrasound.
Benefit:
By participating in the fetal face project the volunteers have an extra
possibility to look at there unborn child with ultrasound.
Group relatedness:
Only healthy pregnant Caucasian women are included.
Koekoekslaan 1
Nieuwegein
Nederland
Koekoekslaan 1
Nieuwegein
Nederland
Listed location countries
Age
Inclusion criteria
Healthy Caucasian prenant women with a singleton pregnancy.
Exclusion criteria
-no Caucasian father
-growth below the 5th percentile
-growth above the 95th percentile
-congenital anomaly
Design
Recruitment
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 | NL12414.100.06 |