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Completed

NCT Number: NCT01594463

Routine Ultrasound Screening in the Third Trimester

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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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound examination

Other

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

Primary outcomes

  1. Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).

    Time frame: At birth

    SGA infant and intrauterine growth restriction are defined using a threshold below the tenth percentile for customized birth weight or customized estimated birth weight.

Secondary outcomes

  1. 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

  2. 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

  3. Maternal complications and neonatal outcomes.

    Time frame: In the postpartum period

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction

Acronym: RECRET

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 9, 2012
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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