Overview

This trial is active, not recruiting.

Conditions fetal growth retardation, high-risk pregnancy
Treatments ultrasound examination
Sponsor University Hospital, Rouen
Start date May 2012
End date March 2016
Trial size 3760 participants
Trial identifier NCT01594463, 2010/090/HP

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
late examination between 34+1 weeks to 35+6 weeks.
ultrasound examination
ultrasound examination between 34+1 weeks to 35+6 weeks
(Experimental)
early examination between 30+1 weeks to 31+6 weeks
ultrasound examination
ultrasound examination between week 30+1 weeks to 31+6 weeks

Primary Outcomes

Measure
Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).
time frame: At birth

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University Hospital, Rouen.