Revealed Versus Concealed Cerebroplacental Ratio

Revealed Versus Concealed Criteria for Placental Insufficiency in Unselected Obstetric Population in Late Pregnancy: a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Stillbirth
• Intervention / Treatment: Other: Revealment

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.

• Study Type: Interventional
• Enrollment (Actual): 11582
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago de Chile, Chile
    • Hospital Clínico Universitario de Santiago de Chile
• Czechia
  • Olomouc, Czechia
    • Palacky University Hospital
  • Prague, Czechia
    • Ladislav Krofta
• Israel
  • Tel Aviv, Israel
    • Eyal Zohav
• Mexico
  • Querétaro, Mexico
    • Hospital de Querétaro
• Poland
  • Warsaw, Poland
    • Anna Kajdy
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic
  • Barcelona, Spain
    • Elena Escazzocchio
  • Barcelona, Spain
    • Elena Ferriols Perez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Revealment; Cerebroplacental ratio revealment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stillbirth	Perinatal death	between 37 and 42 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse perinatal outcome	Severe neurological and non-neurological adverse outcome	Up to 28 days after delivery
Fetal Growth Restriction Detection	To detect prenatal low birth weight	3 years

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Study Chair: Eduard Gratacos, PhD, Hospital Clinic

Publications and helpful links

General Publications

• Figueras F, Gratacos E, Rial M, Gull I, Krofta L, Lubusky M, Cruz-Martinez R, Cruz-Lemini M, Martinez-Rodriguez M, Socias P, Aleuanlli C, Cordero MCP. Revealed versus concealed criteria for placental insufficiency in an unselected obstetric population in late pregnancy (RATIO37): randomised controlled trial study protocol. BMJ Open. 2017 Jun 15;7(6):e014835. doi: 10.1136/bmjopen-2016-014835. Erratum In: BMJ Open. 2019 Feb 19;9(2):e014835corr1.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2016
• Primary Completion (Actual): January 6, 2022
• Study Completion (Actual): January 6, 2022

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: cerebroplacental ratio; fetal growth restriction; stillbirth
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth
• Other Study ID Numbers: RATIO37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No