Trial DesignAssociations between cardiovascular parameters and uteroplacental Doppler (blood) flow patterns during pregnancy in women with congenital heart disease: Rationale and design of the Zwangerschap bij Aangeboren Hartafwijking (ZAHARA) II study
Section snippets
Background
Because of improved long-term survival, most women with congenital heart disease (CHD) reach child-bearing age and many pursue pregnancy. In women with uncorrected maternal congenital heart defects or with residual sequelae after correction, the hemodynamic changes in pregnancy can have negative effects on the health of both mother and her (unborn) child. Cardiac events are rare in healthy women (<1%), while arrhythmias occur in 4.5% and heart failure in 4.8% of women with CHD.1 In complex CHD,
Study objectives
The primary objective of the present study is to compare cardiovascular, neurohumoral, and uteroplacental Doppler flow changes during pregnancies of women with CHD with age- and parity-matched healthy controls and to relate these changes to the occurrence of cardiovascular and obstetric events and to offspring outcome. The secondary objective of this study is to evaluate the incidence of permanent postpartum cardiovascular deterioration in women with CHD.
Study design
This is an observational prospective
Discussion
In the present study, we assess whether changes in cardiovascular, hemodynamic, neurohumoral parameters, and uteroplacental Doppler flow patterns during pregnancy of women with CHD differ from age- and parity-matched healthy controls. We also assess the interaction of these changes with the occurrence of cardiovascular, obstetric, and offspring events. In addition, we evaluate the incidence of permanent changes in cardiovascular parameters 1 year postpartum in women with CHD and compare these
Conclusion
The current ZAHARA II study is the first “in vivo” study in women with CHD to evaluate the effect of compromised cardiac performance on the uteroplacental circulation and its relationship with the occurrence of obstetric events and adverse offspring outcome. By identifying the components responsible for pregnancy-related events in women with CHD, we will refine risk stratification that will lead to better pre-pregnancy counseling and may eventually improve treatment of these women.
References (42)
- et al.
Outcome of pregnancy in women with congenital heart disease: a literature review
J Am Coll Cardiol
(2007) - et al.
Maternal central hemodynamics in hypertensive disorders of pregnancy
Obstet Gynecol
(1999) - et al.
Histomorphology of the placenta and the placental bed of growth restricted foetuses and correlation with the Doppler velocimetries of the uterine and umbilical arteries
Placenta
(2003) - et al.
Late cardiac outcomes after pregnancy in women with congenital aortic stenosis
Am Heart J
(2009) - et al.
Impact of pregnancy on the systemic right ventricle after a Mustard operation for transposition of the great arteries
J Am Coll Cardiol
(2004) - et al.
Task force 1: the changing profile of congenital heart disease in adult life
J Am Coll Cardiol
(2001) - et al.
Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice
J Am Soc Echocardiogr
(2009) - et al.
Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology
J Am Soc Echocardiogr
(2005) - et al.
Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography
J Am Soc Echocardiogr
(2010) - et al.
Induction of nitric oxide synthases early in pregnancy
Am J Obstet Gynecol
(1994)
Early pregnancy changes in hemodynamics and volume homeostasis are consecutive adjustments triggered by a primary fall in systemic vascular tone
Am J Obstet Gynecol
Blood pressure, the renin-aldosterone system and sex steroids throughout normal pregnancy
Am J Med
Cardiac output in normal pregnancy: a critical review
Obstet Gynecol
Usefulness of natriuretic peptide levels to predict mortality in adults with congenital heart disease
Am J Cardiol
New criteria for diagnosis of infective endocarditis: utilization of specific echocardiographic findings. Duke Endocarditis Service
Am J Med
Prospective multicenter study of pregnancy outcomes in women with heart disease
Circulation
Predictors of pregnancy complications in women with congenital heart disease
Eur Heart J
Risk of complications during pregnancy after Senning or Mustard (atrial) repair of complete transposition of the great arteries
Eur Heart J
Doppler ultrasound screening predicts recurrence of poor pregnancy outcome in subsequent pregnancies, but not the recurrence of PIH or preeclampsia
Hypertens Pregnancy
Morphological changes of the spiral arteries in the placental bed in relation to pre-eclampsia and fetal growth retardation
Br J Obstet Gynaecol
Pregnancy outcomes in women with congenital heart disease
Circulation
Cited by (29)
Placental Findings in Pregnancies Complicated by Maternal Cardiovascular Disease
2022, JACC: AdvancesLongitudinal changes in maternal left atrial volume index and uterine artery pulsatility indices in uncomplicated pregnancy
2021, American Journal of Obstetrics and GynecologyDoppler gradients, valve area and ventricular function in pregnant women with aortic or pulmonary valve disease: Left versus right
2020, International Journal of CardiologyCitation Excerpt :All the participating centers received approval of the medical ethics committee and all women (prospectively enrolled) provided written informed consent. The healthy controls were recruited from low risk midwife practices in Groningen and Rotterdam [7]. For the healthy controls, postpartum echocardiograms were also used as baseline measurements.
Biological versus mechanical heart valve prosthesis during pregnancy in women with congenital heart disease
2018, International Journal of CardiologyCitation Excerpt :Pregnancy related complications were collected for all pregnancies and analyzed for completed pregnancies and defined as occurring during pregnancy and up to 6 months postpartum. Pregnancy related complications were defined in accordance with our previous studies and according to guidelines [20,22,23]. We collected prosthesis related cardiovascular complications (including valve deterioration, valve thrombosis, embolism, hemorrhage, endocarditis and hemolytic anemia), other cardiovascular complications (including need for urgent invasive non-prosthesis related cardiovascular procedures, heart failure or arrhythmias requiring (change of) treatment, myocardial infarction, intensive care or coronary care unit (IC/CCU) admission).
Pregnancy in women with corrected aortic coarctation: Uteroplacental Doppler flow and pregnancy outcome
2017, International Journal of CardiologyCitation Excerpt :Primary cardiovascular events were defined as: need for an urgent invasive cardiovascular procedure, heart failure (according to the guidelines of the European Society of Cardiology and documented by the attending physician [15]), new onset or symptomatic tachy- or bradyarrhythmia requiring new or extended treatment, thromboembolic events, myocardial infarction, cardiac arrest, cardiac death, endocarditis and aortic dissection [6,7]. Primary obstetric events included: instrumental vaginal delivery (vacuum or forcipal-extraction), Cesarean section (planned or emergency), pregnancy induced hypertension (PIH), pre-eclampsia (PIH combined with proteinuria), eclampsia (pre-eclampsia with grand mal seizures), gestational Diabetes Mellitus, HELLP syndrome (haemolysis, elevated liver enzymes, low platelet syndrome), hyperemesis gravidarum, non-cardiac death, placental abruption, postpartum hemorrhage, preterm labour and preterm premature rupture of membranes (before 37 weeks gestation) [6]. Offspring events were fetal death (intra-uterine death ≥ 20 weeks gestation), perinatal death (number of stillbirths from 20 weeks gestation and death up to 28 days post-partum), intra-ventricular hemorrhage, neonatal respiratory distress syndrome, preterm birth (before 37 weeks gestation), occurrence of congenital heart disease, small for gestational age (birth weight < 10th percentile) and low birth weight (< 2500 g) [6,7].
Cardiac function and cardiac events 1-year postpartum in women with congenital heart disease
2015, American Heart JournalCitation Excerpt :All echocardiographic recordings were evaluated off-line by 4 experienced cardiologists, blinded to the end points. Chamber quantification, valvular function, and systolic and diastolic ventricular function assessment were performed according to the current recommendations as previously described.13 Cardiovascular events (>6 months after delivery) were assessed during the follow-up visit 1-year postpartum.
This study is supported by a grant from the Netherlands Heart Foundation (NHF) (2007B75). DJvV is clinically established investigator of the NHF (D97-017). The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.