In this study the test characteristics of the early structural ultrasound examination (SUE) (at 13-14 weeks) will be evaluated and compared the those of the standard SUE/AUE at 20 weeks. Also, the amount of (in-)conclusive examinations and the…
ID
Source
Brief title
Condition
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity and specificity of early structural ultrasound compared to normal
midterm ultrasound
Secondary outcome
Amount of abnormalities seen and not seen at the ultrasound examinations, type
of abnormalities and amount of (in-) conclusive examinations and the reasons
for being inconclusive
Background summary
Evaluation of the structural ultrasound examination (SUE) earlier in the
pregnancy (at 13-14 weeks) compared to the SUE/AUE at 20 weeks. The test
characteristics of the ultrasound will be evaluated.
If anomalies of the fetus are seen earlier in pregnancy, there is more time for
eventual follow-up examinations and more time for the parents to think about
continuation or termination of the pregnancy (before the completed termination
term of 24 weeks).
Study objective
In this study the test characteristics of the early structural ultrasound
examination (SUE) (at 13-14 weeks) will be evaluated and compared the those of
the standard SUE/AUE at 20 weeks. Also, the amount of (in-)conclusive
examinations and the reasons why it was inconclusive will be assessed.
Study design
The parents will be (if desired) informed by their midwife/gynaecologist about
the possibilities for prenatal screening. Also, this study will be discussed
and the written information will be given. Pregnant women can call for an
appointment for the ultrasound if they want to participate in this study. About
2000 pregnant women will be included. The expected duration for this study is
18 months.
Study burden and risks
Burden is minimal. Pregnant women have to come once to the ultrasound center
for an ultrasound examination (around 45 min). Probably a transvaginal
ultraosund will be made. This can be experienced as a little uncomfortable. The
examination knows no proved risks for mother and child.It is also used
currently at the 20 weeks ultrasound as standard care.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Pregnant woman
- 18 years of age or older
- Participating in second trimester screening
- Good knowledge of Dutch or English
- Capacity to consent/ good mental competence
Exclusion criteria
- Congenital anomalies seen in previous ultrasound or during first trimester
- Oligo-/anhydramnion
- Contra-indications for transvaginal ultrasound: patient*s refusal
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 | NL45560.068.13 |