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Doppler Modifications in Intrauterine Growth Restricted Fetuses

Withdrawn
Conditions
function of the heart
small for gestational age
10016849
Registration Number
NL-OMON43435
Lead Sponsor
Obstetrie & Gynaecologie
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
40
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

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

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Detecting changes in the fetal hemodynamic system before and after admistration<br /><br>of antenatal corticosteroids in the growth restricted fetus (FGR) compared with<br /><br>the appropriate for gestational age (AGA) fetus.<br /><br>Data about Doppler parameters will be expressed as the number of standard<br /><br>deviations from the respective normal means for gestation (* value). The<br /><br>measurements will be analyzed for each fetus and compared before and after<br /><br>treatment; each fetus will be considered as its own control. The data obtained<br /><br>on the control day (baseline examination) will be considered for significant<br /><br>difference with the measurements acquired in the subsequent ultrasounds. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Changes in the methylation of the HSD11B2 gene after administration of<br /><br>corticosteroids in the growth restricted fetus (FGR) compared with the<br /><br>appropriate for gestational age (AGA) fetus.<br /><br>Methylation analysis will be performed by pyrosequencing. These results are<br /><br>calculated by a computer program and shown as a percentage. Immune parameters<br /><br>will be analyzed by multicolor flowcytometry, rtPCR analysis of RNA, and<br /><br>immunohistologic stainings. </p><br>
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