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Clinical Trials/NCT01594463
NCT01594463
Completed
Not Applicable

Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction

University Hospital, Rouen1 site in 1 country3,760 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fetal Growth Retardation
Sponsor
University Hospital, Rouen
Enrollment
3760
Locations
1
Primary Endpoint
Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of 40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and hospitalization in intensive care unit. The investigators hypothesis that a later third trimester routine ultrasound may be more accurate to diagnose late intrauterine growth restriction.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Accurate gestational dating using crown-rump length at 11-14 weeks
  • Singleton pregnancy
  • Primiparity
  • Normal First trimester (11-14 weeks) and second trimester (20-25 weeks) scans
  • Maternal age \> 18 years
  • No maternal opposition for the study

Exclusion Criteria

  • Maternal diseases i.e. chronic renal disease, hypertension, diabetes, collagen vascular disease, antiphospholipid syndrome
  • Pregnancies with congenital anomalies or foetal growth restriction diagnosed before 30 weeks of gestation

Outcomes

Primary Outcomes

Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).

Time Frame: At birth

SGA infant and intrauterine growth restriction are defined using a threshold below the tenth percentile for customized birth weight or customized estimated birth weight.

Secondary Outcomes

  • Number of neonate with a customized birth weight upper the tenth percentile adequately screened by a routine ultrasound in the third trimester (specificity).(At birth)
  • Number of prenatal consultations, ultrasound scans performed, maternal hospitalization, labor induction, and caesarean section induced by the third trimester routine ultrasound(After the delivery)
  • Maternal complications and neonatal outcomes.(In the postpartum period)

Study Sites (1)

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