Cardiovascular remodeling in small-for-gestational-age fetuses

Fetal programming: Evaluation of cardiovascular remodeling in late-onset small-for-gestational-age fetuses and prediction of adverse birth and intermediate-term cardiovascular outcome

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN36008820

Enrollment

300

Registered

2017-08-02

Start date

2016-09-01

Completion date

Unknown

Last updated

2017-09-04

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

Conditions

Fetal programming, cardiovascular remodeling, late-onset intrauterine growth restriction Pregnancy and Childbirth Late-onset intrauterine growth restriction

Interventions

This study is a prospective longitudinal observational study that includes participants consecutively. All cases are seen at the high risk SGA outpatient ward. The source population is recruited from

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pregnant women aged 18 and older 2. Fetuses with a gestational age = 32 weeks 3. Suspected of growth restriction defined as an estimated fetal weight or fetal abdominal circumference measured below the 10th population or customized percentile or a change of abdominal circumference <5mm in 2 weeks measured by ultrasound

Exclusion criteria

Exclusion criteria: 1. Born <37 weeks gestational age 2. Known chromosomal and/or structural anomaly 3. Multiple gestation 4. Mothers with cardiac heart disease 5. Mothers’ severe systemic disease 6. Antihypertensive medication 7. Antenatal intra-uterine infection

Design outcomes

Primary

Measure	Time frame
Prediction of mean blood pressure (BP) (in mmHg) at one year of age is measured using the average acceleration capacity (bpm), tricuspid annular plane systolic excursion (mm), right sphericity index, Strain-rate, aortic distensibility, isovolumetric relaxation time (ms)) during pregnancy.	—

Secondary

Measure	Time frame
1. Adverse birth outcomes are measured using 1.1. Mortality defined as intra-uterine death or death before hospital discharge 1.2. Acidosis defined as arterial cord blood pH75th centile and/or BP > 95th centile at birth and at 12 months of age 5. Prediction of mean blood pressure (BP) at one year of age (mm Hg) using the following measurements: metabolic profile, fetal functional echocardiographic parameters others than the ones used for primary outcome 6. Correlation of mean blood pressure (BP) at one year of age (mm Hg) and autonomic nervous system [average acceleration and deceleration capacity (bpm)] and antenatal/ fetal functional echocardiographic parameters 7. Correlation of antepartal cardiac function parameters and those at 1 year of life	—

Measure

Time frame

1. Adverse birth outcomes are measured using 1.1. Mortality defined as intra-uterine death or death before hospital discharge 1.2. Acidosis defined as arterial cord blood pH75th centile and/or BP > 95th centile at birth and at 12 months of age 5. Prediction of mean blood pressure (BP) at one year of age (mm Hg) using the following measurements: metabolic profile, fetal functional echocardiographic parameters others than the ones used for primary outcome 6. Correlation of mean blood pressure (BP) at one year of age (mm Hg) and autonomic nervous system [average acceleration and deceleration capacity (bpm)] and antenatal/ fetal functional echocardiographic parameters 7. Correlation of antepartal cardiac function parameters and those at 1 year of life

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026