A study will be conducted to investigate whether screening for PE and growth restriction not associated with PE in the Dutch setting is feasible.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main objective of the study is to evaluate the performance of two existing
algorithms for the prediction of PE and growth restriction not associated with
PE. These algorithms (including the following variables: ethnicity, body mass
index (BMI), mean arterial pressure (MAP), lowest Doppler resistance
measurement (PI) of both uterine arteries and maternal serum blood markers
(PAPP-A and PLGF)) will be tested and other possible combinations of variables
will be evaluated for their predictive ability.
Secondary outcome
Secondary objectives:
- Evaluating the learning curve for measurement of the uterine arteries
- Inter and intra- observer variation of measurement of the uterine arteries
- Quality assessment of the measurements of the uterine arteries
- Time needed to collect informed consent, maternal history and measurement of
the maternal blood pressure and uterine arteries
Background summary
Pre-eclampsia (PE) and intra-uterine growth restriction (GR) are major causes
of maternal and perinatal mortality and morbidity. Pre-eclampsia occurs in
approximately 2% of all pregnancies and is subdivided into early (0.5%) and
late PE (1.5%). It is also more common in nulliparae than in multiparae. Early
PE is associated with iatrogenic preterm birth, maternal and neonatal mortality
and morbidity. Furthermore, PE is also associated with a fourfold increase in
the risk of GR, which is linked to both short-term and long-term health
consequences (Odegard 2000). Fetuses affected by GR are at high risk of
obesity, cardiovascular disease, hypertension, and diabetes later in life
(Barker 1990/2004). Although GR is commonly associated to PE, 5% of GR cases
may share the same pathophysiologic background as PE, but without an increase
in maternal blood pressure (Karagiannis 2011).
Up to now, women with increased risk of PE/ GR were selected on the basis of
their medical history, or based on symptoms that had already manifested (eg.
high blood pressure and / or fetal growth restriction). Recent studies have
shown that it is possible to screen for PE/ GR, in particular early PE, in the
first trimester of pregnancy. The early detection of women at increased risk of
PE is desirable to be able to reduce maternal and fetal mortality and
morbidity. It also provides the opportunity for researching possible
therapeutic options (eg. Aspirin).
Study objective
A study will be conducted to investigate whether screening for PE and growth
restriction not associated with PE in the Dutch setting is feasible.
Study design
Prospective cohort study
Study burden and risks
Participation in this study involves an extra blood sample (10 ml tube), taken
at the same time blood is drawn for routine pregnancy screening in the first
trimester of pregnancy. In addition, an additional 30 minute visit to the
ultrasound clinic is planned to measure blood flow in the uterine arteries
(non-invasive) and maternal blood pressure. Because the feasibility of
screening and of the screenings algorithm is studied, the result of the risk
calculation will not be communicated to the women.
Hanzeplein 1
Groningen Huispostcode CB20
NL
Hanzeplein 1
Groningen Huispostcode CB20
NL
Listed location countries
Age
Inclusion criteria
Primigravida
Viable singleton pregnancy < 12 weeks of gestation
Informed consent given
Exclusion criteria
Minors (being under the age of 18)
Incapacitated persons
Not mastering the Dutch language
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 | NL40178.042.13 |