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Routine Ultrasound Screening in the Third Trimester (RECRET)

Primary Purpose

Fetal Growth Retardation, High-Risk Pregnancy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultrasound examination
ultrasound examination
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fetal Growth Retardation focused on measuring Intrauterine growth restriction, Screening, Ultrasound, Perinatal morbidity, Maternal complications

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

late ultrasound examination

early ultrasound examination

Arm Description

late examination between 34+1 weeks to 35+6 weeks.

early examination between 30+1 weeks to 31+6 weeks

Outcomes

Primary Outcome Measures

Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).
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).
Number of prenatal consultations, ultrasound scans performed, maternal hospitalization, labor induction, and caesarean section induced by the third trimester routine ultrasound
Maternal complications and neonatal outcomes.

Full Information

First Posted
April 27, 2012
Last Updated
May 10, 2016
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01594463
Brief Title
Routine Ultrasound Screening in the Third Trimester
Acronym
RECRET
Official Title
Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Retardation, High-Risk Pregnancy
Keywords
Intrauterine growth restriction, Screening, Ultrasound, Perinatal morbidity, Maternal complications

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3760 (Actual)

8. Arms, Groups, and Interventions

Arm Title
late ultrasound examination
Arm Type
Experimental
Arm Description
late examination between 34+1 weeks to 35+6 weeks.
Arm Title
early ultrasound examination
Arm Type
Experimental
Arm Description
early examination between 30+1 weeks to 31+6 weeks
Intervention Type
Other
Intervention Name(s)
ultrasound examination
Intervention Description
ultrasound examination between week 30+1 weeks to 31+6 weeks
Intervention Type
Other
Intervention Name(s)
ultrasound examination
Intervention Description
ultrasound examination between 34+1 weeks to 35+6 weeks
Primary Outcome Measure Information:
Title
Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).
Description
SGA infant and intrauterine growth restriction are defined using a threshold below the tenth percentile for customized birth weight or customized estimated birth weight.
Time Frame
At birth
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Maternal complications and neonatal outcomes.
Time Frame
In the postpartum period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric VERSPYCK, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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Routine Ultrasound Screening in the Third Trimester

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