Routine Ultrasound Screening in the Third Trimester

University Hospital, Rouen3,760 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

3,760

Conditions

Fetal Growth Retardation High-Risk Pregnancy

Interventions

ultrasound examinationOTHER

ultrasound examination between week 30+1 weeks to 31+6 weeks

ultrasound examinationOTHER

ultrasound examination between 34+1 weeks to 35+6 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Rouen University Hospital

Rouen, France

Outcomes

Primary Outcomes

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.

Time frame: At birth

Secondary Outcomes

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

Data from ClinicalTrials.gov

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