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Clinical Trials/NL-OMON55736
NL-OMON55736
Completed
Not Applicable

DRIGITAT: Doppler Ratio In fetal Growth restriction Intervention Trial At (near) Term - DRIGITAT

Academisch Medisch Centrum0 sites939 target enrollmentTBD
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ConditionsFetal growth restrictionfetal growth retardation10016849

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fetal growth restriction
Sponsor
Academisch Medisch Centrum
Enrollment
939
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Inclusion criteria for the cohort:
  • •\- Singleton pregnancies with identified SGA fetus (EFW/FAC \< p10\)
  • •\- Gestational age from 32\+0 up to and including 36\+6 weeks
  • •Inclusion criteria for the nested RCT:
  • •\- Singleton pregnancies with identified SGA\-fetus (EFW/FAC \< p10\)
  • •\- UCR (UmbilicoCerebral Ratio) \> 0\.8 on at least 2 occasions with an interval
  • •of at least 15 hours (or \- when measurement of PI in the middle cerebral artery
  • •is impossible \- the PI of the umbilical artery is \> p90 on at least 2 occasions
  • •with an interval of at least 15 hours)
  • •\- EFW/FAC \< p3 AND 34\+0 up to and including 36\+6 weeks of gestation

Exclusion Criteria

  • •\- Maternal age \<18 years
  • •\- Inability to give informed consent
  • •\- Uncertainty about the expected due date
  • •\- Suspicion of congenital anomalies which can influence the prognosis of the
  • •pregnancy or health of the fetus
  • •\- Proven chromosomal abnormalities
  • •\- Maternal or fetal indication for short\-term delivery

Outcomes

Primary Outcomes

Not specified

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