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Routine Ultrasound Screening in the Third Trimester (RECRET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594463
First Posted: May 9, 2012
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  Purpose
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.

Condition Intervention
Fetal Growth Retardation High-Risk Pregnancy Other: ultrasound examination

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

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

Enrollment: 3760
Study Start Date: May 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: late ultrasound examination
late examination between 34+1 weeks to 35+6 weeks.
Other: ultrasound examination
ultrasound examination between 34+1 weeks to 35+6 weeks
Experimental: early ultrasound examination
early examination between 30+1 weeks to 31+6 weeks
Other: ultrasound examination
ultrasound examination between week 30+1 weeks to 31+6 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594463


Locations
France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Eric VERSPYCK, Pr Rouen University Hospital
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01594463     History of Changes
Other Study ID Numbers: 2010/090/HP
First Submitted: April 27, 2012
First Posted: May 9, 2012
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by University Hospital, Rouen:
Intrauterine growth restriction
Screening
Ultrasound
Perinatal morbidity
Maternal complications

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes


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