Routine Ultrasound Screening in the Third Trimester

Study Overview
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Brief Summary
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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.

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

Conditions
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Fetal Growth Retardation, High-Risk Pregnancy

Intervention / Treatment
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* Other: ultrasound examination
* Other: ultrasound examination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: late ultrasound examination<br>late examination between 34+1 weeks to 35+6 weeks. | Other: ultrasound examination<br>* ultrasound examination between 34+1 weeks to 35+6 weeks<br>|
| Experimental: early ultrasound examination<br>early examination between 30+1 weeks to 31+6 weeks | Other: ultrasound examination<br>* ultrasound examination between week 30+1 weeks to 31+6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine growth restriction, Screening, Ultrasound, Perinatal morbidity, Maternal complications