The aim of this project is to investigate whether a first trimester model of 3D placental volume, 3D power Doppler measurement of the placental vascularization and/ or serum levels of PAPP-A, PlGF, PP-13, PAI, Ang-2, sFlt and SEng can predict early…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters: Placental vascularisation as described in the
protocol, placental volume/ growth, placental serum markers (PAPP-A, PlGF,
PP-12, PAI, Ang-2, sFlt and Seng)
The main outcome: IUGR.
IUGR is defined as a birth weight percentile p < 5 and a Pulsity Index (PI) of
the umbilical artery p > 95 or absent of end-diastolic flow of the umbilical
artery. IUGR will be divided into Very Severe IUGR needing delivery before 28
weeks gestational age, Early Onset IUGR needing delivery before 34 weeks
gestational age and Late Onset IUGR needing delivery after 34 weeks gestational
age.
Secondary outcome
Secondary study parameters: Size and growth of the Crown-rump length and the
gestational sac, doppler of the artery uterina
Secondary outcomes are small for gestational age, defined as p<10 for
gestational age, and preeclampsia, defined as blood pressure >140/90 mmHg
measured twice six hours apart and proteinuria (> 0.3g in 24 hour urine
collection)
Background summary
IUGR contributes to serious maternal and neonatal morbidity and mortality.
There is morphological and endocrine evidence that early onset IUGR is due to
abnormal placental development. Although early recognition of pregnancies bound
to develop IUGR could improve ante and perinatal care, still no first trimester
prediction model for developing IUGR is known for general practice.
Study objective
The aim of this project is to investigate whether a first trimester model of 3D
placental volume, 3D power Doppler measurement of the placental vascularization
and/ or serum levels of PAPP-A, PlGF, PP-13, PAI, Ang-2, sFlt and SEng can
predict early onset IUGR in a high risk population.
Study design
A prospective case-control study will be carried out in the Erasmus MC,
Rotterdam, The Netherlands.
Study burden and risks
No increased risk is involved. The study population will have 2 to 3 extra
sonographic investigations.
Postbus 2040
3000 CA Rotterdam
Nederland
Postbus 2040
3000 CA Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Women, with a singleton ongoing pregnancy between 4 till 8 weeks gestational age, for both study and control population will be included.
Cases: Women with a previous early onset IUGR (needing delivery before 34 weeks gestational age). In which the IUGR was caused by placental factors and not by infection or congenital disorders. The birth weight must be under the 5th percentile for its gestational age and combined with ultrasonographic signs of an elevated pulsity index of the umbilical cord or an absence or reversed end-diastolic flow.
Controls: At least parity 1, with a previous uncomplicated pregnancy
Exclusion criteria
Multiple pregnancy for both study and control population. Nulliparous women. Women with pre-existing hypertension, diabetes mellitus, systemic diseases, kidney diseases. If a women does not want to be informed whether a physical defect is revealed by the sonography then she will be excluded for this study
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 | NL22459.078.08 |