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ZAHARA 3

 

 

The identification of novel markers for premature delivery; based on investigations in pregnant women with congenital heart defects.

(Zwangerschap bij Aangeboren HARtAfwijkingen.)

 

Go to the Zahara 3 website.


 


Objective

Delivery prior to 37 weeks of gestation is preterm and with a prevalence of 9.6% this yearly affects 14000 babies in the Netherlands alone. Preterm birth is a leading cause of neonatal mortality and morbidity and is strongly associated with aberrant neurological- and motor development in the first years of life. The molecular mechanism that triggers the initiation of parturition has not been identified and there are no prognostic markers available. Treatment can postpone delivery for a short time, probably because the initiating event occurred weeks previously and has progressed too far to stop. Detailed knowledge on the interaction between placenta and myometrium and their role in the initiation of labour is essential to develop diagnostic/prognostic markers and rational therapeutics. In contrast to pregnant women in general, pregnant women with congenital heart disease (CHD)are extremely suitable for investigations on early pregnancy markers and the collection of pregnancy biosamples in relation to preterm premature rupture of membranes (PPROM) and premature labour. Firstly, because they are referred to the antenatal clinic in a tertiary center by their cardiologist comparatively early in pregnancy and thus are available for clinical studies early in pregnancy, and because of the relatively high incidence of premature labour and birth in pregnant CHD women.

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.

 

Study design
It concerns a multicenter observational cohort study with invasive biosampling.

Study population
The study population concerns pregnant women with congenital heart disease, who present at the outpatient clinic of cardiology or obstetrics.

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.

Methods
- At 11-14, 20-24 and 30-34 weeks of gestation obstetric ultrasound evalution will be performed at the prenatal diagnostic policlinic.

- 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.

 

Outcome measures
Obstetric ultrasound data will be related to the occurrence of preterm premature rupture of membranes and premature labour.

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).

 

Power/data analysis
With an overall prevalence of premature deliver of 16% this will result in a minimum of 20 cases versus 130 controls. This is an observational study. Depending on aberrant ultrasound and biomarker profiles, and their sensitivity and specificity, additional studies may be needed.


Time schedule
Start in October 2011, duration 3 years.

Follow up at 11-14 weeks of gestation, at 20-24 weeks of gestation and at 30-34 weeks of gestation.

Projectleaders
Dr. C. Ris-Stalpers, UHD, staffmember department of Obstetrics and gynaecology and reproductive biology laboratory, Academic Medical Center Amsterdam.


Subsidy
This project was funded by ZonMW.

 

Contact

Dr. C. Ris-Stalpers, UHD, staffmember department of Obstetrics and gynaecology and reproductive biology laboratory, Academic Medical Center Amsterdam. c.ris@amc.uva.nl.