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Doppler Modifications in Intrauterine Growth Restricted Fetuses

Doppler Modifications in Intrauterine Growth Restricted Fetuses - DOMINO

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43435
Enrollment
40
Registered
2021-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

function of the heart small for gestational age

Interventions

None listed

Sponsors

Obstetrie & Gynaecologie
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Singleton pregnancies between 24 and 34 weeks gestation diagnosed with FGR (AC * 10th percentile/ decline in growth pattern * 40 percentiles) undergoing antenatal steroids (AS) (betamethasone 12 mg i.m. 2 doses 24 hours apart) for medical indication. - Singleton pregnancies between 24 and 34 weeks gestation with AGA fetuses (EFW * 10th percentile, AC* 10th percentile, normal growth pattern, normal umbilical artery (UA) and uterine arteries (AAUt) Dopplers) undergoing AS for medical indication.

Exclusion criteria

Exclusion criteria: Maternal age under 18 years Not capable of speaking and reading the Dutch language Multiple pregnancies Congenital abnormalities Abnormal fetal karyotype

Design outcomes

Primary

MeasureTime frame
Detecting changes in the fetal hemodynamic system before and after admistration of antenatal corticosteroids in the growth restricted fetus (FGR) compared with the appropriate for gestational age (AGA) fetus. Data about Doppler parameters will be expressed as the number of standard deviations from the respective normal means for gestation (* value). The measurements will be analyzed for each fetus and compared before and after treatment; each fetus will be considered as its own control. The data obtained on the control day (baseline examination) will be considered for significant difference with the measurements acquired in the subsequent ultrasounds.

Secondary

MeasureTime frame
Changes in the methylation of the HSD11B2 gene after administration of corticosteroids in the growth restricted fetus (FGR) compared with the appropriate for gestational age (AGA) fetus. Methylation analysis will be performed by pyrosequencing. These results are calculated by a computer program and shown as a percentage. Immune parameters will be analyzed by multicolor flowcytometry, rtPCR analysis of RNA, and immunohistologic stainings.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)