Routine Ultrasound Screening in the Third Trimester

Fetal Growth Retardation Clinical Trial

— RECRET  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01594463
• Other study ID #: 2010/090/HP
• Status: Active, not recruiting
• Phase: N/A
• First received: April 27, 2012
• Last updated: January 22, 2016
• Start date: May 2012
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3760
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fetal Growth Retardation
• High-Risk Pregnancy

Intervention

Other:
• ultrasound examination
ultrasound examination between week 30+1 weeks to 31+6 weeks
• ultrasound examination
ultrasound examination between 34+1 weeks to 35+6 weeks

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At birth	No
Secondary	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	No
Secondary	Number of prenatal consultations, ultrasound scans performed, maternal hospitalization, labor induction, and caesarean section induced by the third trimester routine ultrasound		After the delivery	No
Secondary	Maternal complications and neonatal outcomes.		In the postpartum period	No