a) To evaluate whether PAPP-A2 and inhibin A could be used as biomarkers for preeclampsia and preeclampsia-related outcome in twin pregnancies. To achieve this objective, we will first assess:- Whether PAPP-A2 and inhibin A levels are increased in…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. PAPP-A2 and inhibin A levels in twin PE pregnancies versus twin healthy
pregnancies.
2. PAPP-A2 and inhibin A levels in twin (healthy) pregnancies in comparison
to singleton (healthy) pregnancies.
Secondary outcome
- Biomarker level course across gestational age (PAPP-A2, inhibin A,
sFlt-1 and PlGF) in twin pregnancies in women with healthy vs. confirmed PE.
- Correlation between PAPP-A2, inhibin A, sFlt-1 en PlGF levels in twin
pregnancies.
Background summary
The biomarkers PAPP-A2 and inhibin A have been recently identified as promising
biomarkers to predict preeclampsia-related complications in singleton
pregnancies with suspected or confirmed PE. However, their potential role as
predictors in twin pregnancies has not been evaluated yet. In this proof of
concept study, we wanted to compare the values of PAPP-A2 and inhibin A between
twin and singleton pregnancies without PE and evaluate whether these biomarkers
are also increased in twin pregnancies with PE in comparison to pregnancies
without PE.
Study objective
a) To evaluate whether PAPP-A2 and inhibin A could be used as biomarkers for
preeclampsia and preeclampsia-related outcome in twin pregnancies. To achieve
this objective, we will first assess:
- Whether PAPP-A2 and inhibin A levels are increased in twin PE pregnancies
versus healthy twin pregnancies.
- Whether PAPP-A2 and inhibin A levels are increased in healthy twin
pregnancies when compared to healthy singleton pregnancies.
Study design
This will be a case-control proof-of-concept study conducted at the Erasmus
Medical Center, Rotterdam.
Study burden and risks
N/A
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Healthy Controls:
- Women with a twin pregnancy
- Age >= 18 years
- No pre-existing hypertension, proteinuria, renal or other autoimmune disease
- No suspicion of PE
- No suspicion of fetal growth restriction
- Gestational age >=20 weeks and <37 weeks.
Women with confirmed PE:
- Women with a twin pregnancy
- Age >= 18 years
- Confirmed PE
- Alive fetus without fetal distress requiring immediate delivery
- Gestational age >= 20 weeks and <37 weeks.
Exclusion criteria
- The presence of fetal death at time of inclusion.
- Pregnancy with a fetus affected by major congenital birth defects and/or
chromosomal abnormalities
- Unable to provide written informed consent.
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 | NL74813.078.20 |