The RIVM, UMCU and VUmc collectively will perform a prospective study in which the screening value of ADAM12 and PP13 for chromosomal abnormalities and adverse pregnancy outcome will be investigated.
ID
Source
Brief title
Condition
- Ear and labyrinthine disorders congenital
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The goal of this study is to determine differences in screening performance
expressed as detection rate (DR), false positive rate (FPR) and odds of being
affected given a positive result (OAPR). This will be analysed for the combined
test with and without ADAM-12.
Secondary outcome
Attention will be given to the fact if ADAM12 and PP13 have predictive value
for adverse pregnancy outcome.
Background summary
In the Netherlands prenatal screening for Down syndrome, trisomy 21, is
currently performed with the first trimester combined test. This test is
conducted between 8 and 13 weeks of pregnancy.
The risk calculation for Down syndrome is based on maternal age, ultrasound
nuchal translucency measurement (NT) and maternal biochemical markers namely
the free * subunit of hCG (fß-hCG) and pregnancy-associated plasma protein-A
(PAPP-A), with a cut-off level of 1:200. To women with a screen positive result
after prenatal screening a diagnostic test is offered. Prenatal diagnostic
tests give certainty about the number of chromosomes of the foetus.
The predictive value of first trimester maternal serum markers for foetal
chromosome abnormalities is well known. Whether these first trimester
biochemical markers also have a predictive value of adverse pregnancy outcome,
intra-uterine foetal growth restriction, pregnancy induced hypertension or
preterm delivery has not been very well investigated and does not have clinical
importance yet.
ADAM stands for *a disintegrin and metalloprotease* is a metalloproteases and
is produced by the placenta. A potential value of ADAM12 as an indicator of
foetal chromosomal abnormalities has been suggested. It was shown that ADAM12
concentrations are reduced in cases with Down syndrome or other chromosomal
abnormalities. Also a possible role for ADAM12 as predictor of preeclampsia and
intra uterine foetal growth restriction (IUGR) is suggested.
Placental Protein 13 (PP13) is also produced by the placenta. Low PP13
concentrations are associated with abnormal implantation of the placenta.
Therefore, PP13 seems to have potential value as screening marker for
preeclampsia.
Study objective
The RIVM, UMCU and VUmc collectively will perform a prospective study in which
the screening value of ADAM12 and PP13 for chromosomal abnormalities and
adverse pregnancy outcome will be investigated.
Study design
Research goal is to include approximately 20,000 pregnancies in two years of
study (singleton pregnancies only). The combined test will be conducted in the
standard fashion.
Patients willing to participate in the ADAM12 /PP13 study will be asked to
agree in having a second blood sample taken. The first sampling for free *-hCG
and PAPP-A will be performed as early as possible (8-10 weeks of gestation).
The second sampling is scheduled at the same day as the NT-measurement (12-13
weeks of gestation).
ADAM12 and PP13 concentrations will be additionally analysed for study
objectives in both samples. In the study, the test results reported to the
pregnant women are based on the current risk estimation. Pregnant women will
not receive test results based on the ADAM-12/PP-13 concentrations. Pregnancy
outcomes will be evaluated by questionnaire
Study burden and risks
The study will not bring any risk for the subjects.
De Boelelaan 1117
1007 HV Amsterdam
Nederland
De Boelelaan 1117
1007 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Pregnant, singleton
Between 8-10 weeks gestation.
Exclusion criteria
Multiple pregnancies.
Gestation more than 10 weeks.
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 | NL17176.029.08 |