Healthy heart, healthy pregnancy? How a woman's periconceptional cardiovascular health affects pregnancy outcome.

Hemodynamic Adaptation to Pregnancy and Placenta-related Outcome

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25494

Enrollment

300

Registered

2018-10-23

Start date

2019-01-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia Pregnancy induced hypertension Fetal growth restriction Small for gestational age Cardiovascular disease risk Pre-eclampsie (zwangerschapsvergiftiging) Zwangerschapshypertensie (hoge bloeddruk in de zwangerschap) Foetale groeivertraging Te laag geboortegewicht Cardiovasculair risicoprofiel

Interventions

- Echocardiography - Non-invasive vascular measurements (post-occlusive reactive hyperemia

pulse wave analysis) - Cardiopulmonary exercise test with bioimpedance monitoring - Transvaginal ultrasound (preconceptional, first trimester of pregnancy and after delivery) - Transabdominal ultra

Eligibility

Inclusion criteria

Inclusion criteria: - Female - Age above 18 years old - Current wish to get pregnant - Previous pregnancy and delivery more than one year ago - The previous pregnancy was either complicated by preeclampsia/HELLP or fetal growth restriction (high risk group) OR the previous pregnancy was uncomplicated and resulted in a term delivery (low risk group)

Exclusion criteria

Exclusion criteria: - Women unable or unwilling to provide informed consent - Women currently breastfeeding

Design outcomes

Primary

Measure	Time frame
The primary outcome measure of the HAPPO study is the difference in maternal hemodynamic adaptation to pregnancy, expressed as the trajectory of cardiac output assessed by echocardiography before, during and after pregnancy, between women who do and do not develop placenta-related pregnancy complications	—

Secondary

Measure	Time frame
The secondary outcome measures are differences in additional indices of maternal hemodynamic adaptation to pregnancy and utero(placental) vascular development between women who do and do not develop placenta-related pregnancy complications. This includes differences in weight gain during pregnancy, blood pressure, systemic vascular resistance, left ventricular diastolic function, endothelial regulated microvascular function, pulse wave analysis, hemodynamic response to exercise, placental vascular indices, foetal growth parameters (including Doppler measurements) and placenta/placental bed pathology examinations.	—

Measure

Time frame

The secondary outcome measures are differences in additional indices of maternal hemodynamic adaptation to pregnancy and utero(placental) vascular development between women who do and do not develop placenta-related pregnancy complications. This includes differences in weight gain during pregnancy, blood pressure, systemic vascular resistance, left ventricular diastolic function, endothelial regulated microvascular function, pulse wave analysis, hemodynamic response to exercise, placental vascular indices, foetal growth parameters (including Doppler measurements) and placenta/placental bed pathology examinations.

—

Contacts

Public ContactWendy Koster

Erasmus MC

HAPPO.studie@erasmusmc.nl0107043599

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)