Routine Ultrasound Screening in the Third Trimester

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-03-31

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.

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Detailed Description

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Conditions

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Fetal Growth Retardation High-Risk Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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late ultrasound examination

late examination between 34+1 weeks to 35+6 weeks.

Group Type EXPERIMENTAL

ultrasound examination

Intervention Type OTHER

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

early ultrasound examination

early examination between 30+1 weeks to 31+6 weeks

Group Type EXPERIMENTAL

ultrasound examination

Intervention Type OTHER

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

Interventions

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ultrasound examination

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

Intervention Type OTHER

ultrasound examination

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No