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Pilot urinary markers and fetal growth restriction.


- candidate number25487
- NTR NumberNTR6121
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-okt-2016
- Secondary IDsNL201600513 METc UMCG
- Public TitlePilot urinary markers and fetal growth restriction.
- Scientific TitleH2S as urinary marker for fetal growth restriction, a pilot study
- ACRONYMFGR, H2S
- hypothesisGaseous signaling molecules influence placental vasomotor activity to compensate for hypoxemia. Metabolites of these vasoactive molecules can be found in the blood and urine and can indicate whether this (compensatory) mechanism is used to enhance placental function.
- Healt Condition(s) or Problem(s) studiedFetal growth retardation
- Inclusion criteriaInclusions in 5 groups , with n=12 in every group.
-Group 1 Pregnant women 18-40 yr with FGR and without hypertension (between 24 and 36 weeks of gestation):
1A: early and severe FGR (discovered <32 weeks, AC/EFW < p3 or Abnormal End Diastolic Flow (AEDF)) partly from the non-randomized population from existing study: Strider. These women do not receive study medication but they allow follow up of their pregnancy and outcome details including placental investigations) n=12
1B: late severe FGR (discovered >32 weeks, AC/EFW -Group 2: Pregnant women 18-40 yr with FGR with hypertension (between 24 and 36 weeks of gestation): (both early and late severe FGR, may also be overlap with the non-randomized population of the Strider study)
-Group 3: Pregnant women 18-40 yr with SGA ( -Group 4 : Controls: pregnant women 18-40 yr with normal estimated fetal growth along own growth centile between 40th and 60th percentile, no comorbidities. (between 24 and 36 weeks of gestation)
- Exclusion criteriao Congenital anomalies
o Being unable to understand the study information either caused by language differences or low IQ
o Ruptured membranes
o Autoimmune disease
o Diabetes Mellitus
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
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-dec-2016
- planned closingdate1-jun-2017
- Target number of participants60
- InterventionsNot applicable
- Primary outcomeUrinary and blood metabolites related to fetal growth restriction (birthweight and other parameters of growth restriction in the neonate)
- 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
- TimepointsDuring third trimester
- Concentrations of metabolites of the transsulfuration pathway in the urine, measured by ELISA procedures (primary outcome).
- metabolites in maternal and fetal blood (secondary outcome)
- Doppler abnormalities (secondary outcome)

Around birth:
placental histology, APGAR-score (secondary outcomes)
- Trial web sitenone
- statusplanned
- CONTACT FOR PUBLIC QUERIESMw. N. Salavati
- CONTACT for SCIENTIFIC QUERIESDr. S.J. Gordijn
- Sponsor/Initiator Stimuleringsfonds verloskunde
- Funding
(Source(s) of Monetary or Material Support)
Fund = Initiator = Sponsor
- 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)
- RECORD31-okt-2016 - 3-jan-2017


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