Currently, a major issue in fetuses with FGR is the diagnostic process. Children born below a certain population based centile are either constitutionally small or growth restricted. Children grown above that centile may be growth restricted…
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Verkorte titel
Aandoening
Fetal growth restriction (FGR) occurs in 10% of all pregnancies. FGR is multifactorial, as it is associated with various conditions, like maternal diseases, chromosomal abnormalities and infections. Placental insufficiency, resulting in hypoxia, is the most important underlying mechanism in FGR. In most of the cases the fetus doesn¡¦t reach its biological growth potential due to placental insufficiency. These fetuses with FGR are born preterm and have an increased risk for short and long-term morbidity and mortality. They have a higher risk on neurological developmental disorders and a higher risk of cardiovascular diseases on the long term.
Keywords: fetal growth restriction, FGR, metabolite, diagnostic, hydrogen sulfide, sulfate, urine, markers
Keywords dutch: foetale groeirestrictie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Urinary and blood metabolites of the transsulfuration pathway (thiosulfate, sulfite,sulfate).
Achtergrond van het onderzoek
There is need for early predictors for FGR that are easy to measure, inexpensive and, preferably, easy to sample. It is known that several gaseous signaling molecules such as H2S, CO and NO play a role in the (compensatory) mechanism of FGR since they are involved in blood pressure regulation, inflammation and reactive oxygen (ROS) scavenging.
In this pilot study we aim to find a predictive marker with possible therapeutic potential for FGR that is easily available, non-invasive and inexpensive.
Doel van het onderzoek
Currently, a major issue in fetuses with FGR is the diagnostic process. Children born below a certain population based centile are either constitutionally small or growth restricted. Children grown above that centile may be growth restricted although their weight seems to be normal. If we use p10 as a cut off we know that 50% of babies indicated as FGR are in fact healthy small babies and we miss 50% of babies who are growth restricted and are grown above the p10. The distinction between FGR and small for gestational age (SGA) fetuses is important, because where FGR fetuses are pathologically small (irrespective of the growth percentile), SGA fetuses are physiologically small. Consequently, these SGA fetuses are at low risk for adverse perinatal outcomes.
The objective of the study is to find a (non-invasive) biomarker in the urine of pregnant women, which can predict, in combination with biometrical and Doppler measurements, the (severity of) occurence of fetal growth restriction (FGR. Biomarkers we are interested are metabolites of hydrogen sulfide (transsulfuration pathway) that are excreted in the urine (e.g. sulfate which is the most stabile metabolite).
Our hypothesis is that gaseous vasoactive molecules influence placental vasomotor activity to compensate for hypoxemia. Metabolites of these vasoactive molecules can be found in the urine and blood and can indicate whether this (compensatory) mechanism is used to enhance placental function.
Onderzoeksopzet
Primary outcomes:
Concentrations of metabolites of the transsulfuration pathway in the urine, measured by ELISA procedures.
Secondary outcomes:
placental histology, metabolites in maternal and fetal blood, APGAR-score, Doppler abnormalities.
Onderzoeksproduct en/of interventie
Not applicable
Publiek
S.J. Gordijn
Groningen
The Netherlands
s.j.gordijn@umcg.nl
Wetenschappelijk
S.J. Gordijn
Groningen
The Netherlands
s.j.gordijn@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Group 1:
o Pregnant women aged 18-40 years
o Between 24 - 36 weeks of pregnancy
o Diagnosed with FGR:
„X AC/EFW
„X Pulsatility index (PI) umbilical artery >p95 or PI uterine artery >p95
o No other comorbidities
o Group 1A: FGR diagnosed before 34 weeks of gestation (early late)
o Group 1b: FGR diagnosed after 34 weeks of gestation (late early)
Group 2:
o Pregnant women aged 18-40 years
o Diagnosed with FGR (early or late):
„X AC/EFW
„X Pulsatility index (PI) umbilical artery >p95 or PI uterine artery >p95
o Diagnosed with hypertension according to the WHO criteria (sBP > 140mmHg and dBP > 90 mmHg)
Group 3:
o Pregnant women aged 18-40 years
o Between 24 - 36 weeks of pregnancy
o Diagnosed with SGA
„X EFW
o No comorbidities
Group 4:
o Pregnant women aged 18-40 years
o Between 24 - 36 weeks of pregnancy
o Estimated growth between 40th and 60th percentile
o No comorbidities
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
o Congenital anomalies
o Being unable to understand the study information either caused by language differences or low IQ
o Ruptured membranes
o Diabetes Mellitus (defined as use of insulin)
o Renal disease
o Seropositive for HIV
o HELLP
o Urinary tract infection at the moment of collecting urine.
o Multiple pregnancies
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6048 |
| NTR-old | NTR6187 |
| CCMO | NL20160.018.07 |
| OMON | NL-OMON32015 |