Routine Ultrasound Screening in the Third Trimester
This trial is active, not recruiting.
|Conditions||fetal growth retardation, high-risk pregnancy|
|Sponsor||University Hospital, Rouen|
|Start date||May 2012|
|End date||March 2016|
|Trial size||3760 participants|
|Trial identifier||NCT01594463, 2010/090/HP|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).
time frame: At birth
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
Female participants from 18 years up to 50 years old.
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
|Official title||Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction|
|Principal investigator||Eric VERSPYCK, Pr|
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