Assessment of whether fetal RHD genotyping can be performed earlier in pregnancy, i.e. around GW11 instead of the moment around GW27.
ID
Source
Brief title
Condition
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Accuracy of fetal RHD genotyping in comparison to the reference standard as
measured by the sensitivity, specificity, false negative rate, false positive
rate, positive predictive value, negative predictive value, proportion of
technical failures.
Secondary outcome
not applicable
Background summary
Non-invasive fetal RHD genotyping in the context of the national antenatal
population screening program PSIE (Prenatal Screening for Infectious Diseases
and Erythrocyte Immunisation) is performed on the RHD genotyping platform at
Sanquin Diagnostic Services in Amsterdam and takes place in daily practice in
gestational weeks (GW) 27 to 29; and is known as *GW27 screening*. De Haas et
al. have evaluated the accuracy of the fetal RHD screening platform at Sanquin
and have shown that the fetal RHD genotyping procedure is highly reliable and
can be efficiently used for guiding the targeting of anti-RhD immunoprophylaxis
(RhIg) to RhD-negative women pregnant with an RhD-positive fetus.
Interestingly, it has been described that equally high sensitivities (>99%) for
fetal RHD genotyping can be achieved already early in pregnancy, as long as
fetal RHD genotyping is not performed before GW11. Knowledge of the fetal RhD
type early in pregnancy (
Study objective
Assessment of whether fetal RHD genotyping can be performed earlier in
pregnancy, i.e. around GW11 instead of the moment around GW27.
Study design
Prospective assessment of the platform*s fetal RHD genotyping accuracy in
comparison to the reference standard, i.e. fetal RHD genotyping as part ofGW27
screening.
Study burden and risks
For this study an extra tube of blood needs to be collected during a regular
blood collection appointment around GW11. This represents no significant burden
to the pregnant mother, since both the regular and extra blood tube will be
collected in one and the same venepuncture procedure and taking into account
the small volume of 10 mL of blood. The study will include RhD-negative
multiparous women and all primigravida women, for their RhD status is not known
when PSIE screening is done. It will provide a benefit to RhD-negative pregnant
women in terms of more personalized follow-up in pregnancy with more restricted
testing and quality assurance for the optimal moment for fetal RhD typing in
pregnancy. Finally, data collection concerns the procedure of fetal RHD
genotyping, which is already routinely performed as part of the national
antenatal population screening program and only women participating in this
program will be approached for the study.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Pregnant
RhD-negative multiparous
RhD-negative primigravida
Unknown RhD status in primigravida
Women should be able for the first trimester PSIE pregnancy screening
Exclusion criteria
Not applicable
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL82339.000.23 |