Routine Ultrasound Screening in the Third Trimester (RECRET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01594463
First received: April 27, 2012
Last updated: September 1, 2014
Last verified: September 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maternal complications and neonatal outcomes. [ Time Frame: In the postpartum period ] [ Designated as safety issue: No ]

Estimated Enrollment: 4134
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594463

Contacts
Contact: Eric VERSPYCK, MD, PhD 00332888745 eric.verspyck@chu-rouen.fr

Locations
France
Rouen University Hospital Recruiting
Rouen, France, 76031
Contact: Eric Verspyck, MD, PhD    00332888745    eric.verspyck@chu-rouen.fr   
Principal Investigator: Eric VERSPYCK, MD PhD         
Sub-Investigator: Gérard LABADIE, MD         
Sub-Investigator: Marie BRASSEUR-DAUDRUY, MD         
Sub-Investigator: Véronique WILMORT, MD         
Sub-Investigator: Sophie DEGRE, MD         
Sub-Investigator: Marie-Noëlle PLAGNOL, MD         
Sub-Investigator: Caroline BLONDEL-MEUNIER, MD         
Sub-Investigator: Philippe LEBOULLENGER, MD         
Sub-Investigator: Stéphanie HARDEMAN, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Eric VERSPYCK, Pr Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01594463     History of Changes
Other Study ID Numbers: 2010/090/HP
Study First Received: April 27, 2012
Last Updated: September 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on October 20, 2014