Routine Ultrasound Screening in the Third Trimester

NCT01594463 | Completed

• 1 other identifier: 2010/090/HP
• Study Type: interventional
• Target: 3,760
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Growth Retardation; High-Risk Pregnancy

Keywords

Intrauterine growth restriction; Screening; Ultrasound; Perinatal morbidity; Maternal complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

late ultrasound examination

EXPERIMENTAL

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

Other: ultrasound examination

early ultrasound examination

EXPERIMENTAL

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

Other: ultrasound examination

Interventions

ultrasound examination OTHER

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

early ultrasound examination

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric VERSPYCK, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 9, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

FR (1)