Revealed Versus Concealed Cerebroplacental Ratio

Overview

The purpose of this study is to evaluate the role of an integrated strategy at selecting fetuses for delivery at term based on a combination of fetal biometry and cerebroplacental ratio (CPR) to reduce stillbirth rate and adverse perinatal outcome.

Full Title of Study: “Revealed Versus Concealed Criteria for Placental Insufficiency in Unselected Obstetric Population in Late Pregnancy: a Multicenter Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2018

Detailed Description

This is a multicenter, open-label randomized trial with groups in parallel. Singleton pregnancies are recruited after routine second trimester scan (19+0 to 22+6 weeks of gestation) and randomly allocated at that moment to revealed or concealed strategy. A routine scan will be booked at 36-37 weeks. For a reduction of the stillbirth rate of 3‰ (from 5‰ to 2‰), assuming a type I error of 5% and aiming for a power of 80% a total of 11,582 subjects (5791 per arm) were projected. The participating centers sum up 12,000 deliveries a year. It is not possible to blind participants, obstetricians, or outcome assessors to the study group.

General hypothesis: A proportion of fetuses with "normal" growth as per current standards have placental insufficiency and restriction of their growth potential. These fetuses exhibit biophysical changes expressed by abnormal cerebroplacental ratio. A combination of this marker with fetal biometry for the detection of fetuses affected by fetal growth restriction could identify a group of babies on which labor induction once term is reached may prevent the occurrence of adverse outcomes.

Specific hypothesis

- The cerebroplacental ratio has predictive value in late pregnancy for placental insufficiency.

- The cerebroplacental ratio could improve the effectiveness of late pregnancy screening for the prediction placental insufficiency-related complications.

Interventions

  • Other: Revealment
    • Cerebroplacental ratio revealment

Arms, Groups and Cohorts

  • No Intervention: Concealment
    • Cerebroplacental ratio measurement at 37 weeks of pregnancy only taken into account if estimated fetal weight <p10
  • Other: Revealment
    • Cerebroplacental ratio measurement at 37weeks and labor induction in case of cerebroplacental ratio <p5

Clinical Trial Outcome Measures

Primary Measures

  • Stillbirth
    • Time Frame: between 37 and 42 weeks of pregnancy

Secondary Measures

  • Adverse perinatal outcome
    • Time Frame: Up to 28 days after delivery
  • Fetal Growth Restriction Detection
    • Time Frame: 3 years

Participating in This Clinical Trial

Inclusion Criteria

  • Viable singleton non-malformed fetus
  • Available first-trimester US dating
  • Maternal age at recruitment ≥18 years
  • No adverse medical or obstetrical history at booking
  • Capacity to give informed consent

Exclusion Criteria

  • Abnormal karyotype
  • Structural abnormalities
  • Congenital infections

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital Clinic of Barcelona
  • Provider of Information About this Clinical Study
    • Principal Investigator: Francesc Figueras, Obstetrics Department Head Hospital Clinic Barcelona – Hospital Clinic of Barcelona
  • Overall Official(s)
    • Eduard Gratacos, PhD, Study Chair, Hospital Clinic
  • Overall Contact(s)
    • Francesc Figueras, PhD, 0034932279946, ffiguera@clinic.cat

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