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Urinary markers and fetal growth restriction


- candidate number25446
- NTR NumberNTR6187
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2016
- Secondary IDsNL201600513 Ethical board (METC)
- Public TitleUrinary markers and fetal growth restriction
- Scientific TitleUrinary markers and fetal growth restriction
- ACRONYM-
- hypothesisCurrently, 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.
- Healt Condition(s) or Problem(s) studiedFetal growth retardation
- Inclusion criteriaGroup 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
- Exclusion criteriao 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-nov-2016
- planned closingdate1-nov-2017
- Target number of participants60
- InterventionsNot applicable
- Primary outcomeUrinary and blood metabolites of the transsulfuration pathway (thiosulfate, sulfite,sulfate).
- Secondary outcomeo Doppler patterns in umbilical artery and median cerebral artery (MCA)
o composite neonatal outcome
o composite maternal outcome
o placental findings
o placental bed findings
o methylation differences
o immunologic differences
- TimepointsPrimary 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.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. S.J. Gordijn
- CONTACT for SCIENTIFIC QUERIESDr. S.J. Gordijn
- Sponsor/Initiator Stimuleringsfonds verloskunde
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- Publications
- Brief summaryThere 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.
- Main changes (audit trail)
- RECORD21-okt-2016 - 19-feb-2017


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