Routine Ultrasound Screening in the Third Trimester

Not Applicable

Completed

• Conditions: Fetal Growth Retardation; High-Risk Pregnancy
• Interventions: Other: ultrasound examination

• Registration Number: NCT01594463
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-27
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3760

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
late ultrasound examination	ultrasound examination	late examination between 34+1 weeks to 35+6 weeks.
early ultrasound examination	ultrasound examination	early examination between 30+1 weeks to 31+6 weeks

Primary Outcome Measures

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

Name	Time	Method
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

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France