Routine Ultrasound Screening in the Third Trimester (RECRET)

University Hospital, Rouen

Status: Completed

Conditions: High-Risk Pregnancy; Fetal Growth Retardation

Treatments: Other: ultrasound examination

Study type: Interventional

Funder types: Other

Identifiers

NCT01594463

2010/090/HP

Details and patient eligibility

About

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.

Enrollment: 3,760 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,760 participants in 2 patient groups

late ultrasound examination

Experimental group

Description:

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

Treatment:

Other: ultrasound examination

Other: ultrasound examination

early ultrasound examination

Experimental group

Description:

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

Treatment:

Other: ultrasound examination

Other: ultrasound examination