The identification of novel markers for premature delivery; based on investigations in pregnant women with congenital heart defects.
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Go to the Zahara 3 website.
Delivery prior to 37 weeks of gestation is preterm and with a prevalence of 9.6% this yearly affects 14000 babies in the
The primairy objective of ZAHARA 3 is to investigate if pregnant women with CHD who deliver prematurely, compared to pregnant CHD women who do not, display altered fetal and/or placental ultrasound characteristics in the 1st or 2nd trimester of pregnancy that can be used as early pregnancy diagnostic tools for premature labour in the general pregnant population.
Another objective is to obtain a sustainable biobank containing, placenta, placenta bed and myometrium biopsies combined with clinical data to investigate tissue specific expression profiles that relate to preterm premature rupture of membranes and premature labour.
Every pregnant woman with congenital heart disease is eligible for enrollment. The only exclusion criterion is HIV positivity.
A minimum of 150 patients needs to be included with a maximum of 300 patients.
- Blood and urine will be collected at 11-14 and 20-24 weeks of gestation and will be stored in the ZAHARA 3 biobank.
- After delivery of the baby and placenta, placenta biopsies will be taken and stored in the biobank. In case of a caesarian section, also placenta bed and myometrium biopsies will be taken.
- Cardiac follow up is preformed according to the current ESC guidelines ‘Cardiovascular diseases during pregnancy’.
- All ultrasound data, data on pregnancy course and outcome and clinical data of the mother (including the cardiovascular follow up data) will be collected.
- The collected biosamples will be used to investigate obstetrical disease related biomarker profiles.
Additional outcome measures are:
- Cardiovascular complications (i.e. arrhythmia, heartfailure, cardiac death).
- Obstetric complications (i.e. pregnancy induced hypertension, pre-eclampsia).
- Neonatal complications (i.e. premature birth, small for gestational age, mortality).
Follow up at 11-14 weeks of gestation, at 20-24 weeks of gestation and at 30-34 weeks of gestation.
ContactDr. C. Ris-Stalpers, UHD, staffmember department of Obstetrics and gynaecology and reproductive biology laboratory, Academic Medical Center Amsterdam. firstname.lastname@example.org.