NCT02907242

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,582

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
6 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

5.7 years

First QC Date

August 1, 2016

Last Update Submit

April 11, 2022

Conditions

Stillbirth

Keywords

stillbirthcerebroplacental ratiofetal growth restriction

Outcome Measures

Primary Outcomes (1)

  • Stillbirth

    Perinatal death

    between 37 and 42 weeks of pregnancy

Secondary Outcomes (2)

  • Adverse perinatal outcome

    Up to 28 days after delivery

  • Fetal Growth Restriction Detection

    3 years

Study Arms (2)

Concealment

NO INTERVENTION

Cerebroplacental ratio measurement at 37 weeks of pregnancy only taken into account if estimated fetal weight \<p10

Revealment

OTHER

Cerebroplacental ratio measurement at 37weeks and labor induction in case of cerebroplacental ratio \<p5

Other: Revealment

Interventions

RevealmentOTHER

Cerebroplacental ratio revealment

Revealment

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Abnormal karyotype
  • Structural abnormalities
  • Congenital infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hospital Clínico Universitario de Santiago de Chile

Santiago, Chile

Location

Palacky University Hospital

Olomouc, Czechia

Location

Ladislav Krofta

Prague, Czechia

Location

Eyal Zohav

Tel Aviv, Israel

Location

Hospital de Querétaro

Querétaro, Mexico

Location

Anna Kajdy

Warsaw, Poland

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Elena Escazzocchio

Barcelona, Spain

Location

Elena Ferriols Perez

Barcelona, Spain

Location

Related Publications (2)

  • Rial-Crestelo M, Lubusky M, Parra-Cordero M, Krofta L, Kajdy A, Zohav E, Ferriols-Perez E, Cruz-Martinez R, Kacerovsky M, Scazzocchio E, Roubalova L, Socias P, Haslik L, Modzelewski J, Ashwal E, Castella-Cesari J, Cruz-Lemini M, Gratacos E, Figueras F; RATIO37 Study Group. Term planned delivery based on fetal growth assessment with or without the cerebroplacental ratio in low-risk pregnancies (RATIO37): an international, multicentre, open-label, randomised controlled trial. Lancet. 2024 Feb 10;403(10426):545-553. doi: 10.1016/S0140-6736(23)02228-6. Epub 2024 Jan 11.

    PMID: 38219773DERIVED

  • 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.

    PMID: 28619771DERIVED

MeSH Terms

Conditions

StillbirthFetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth Disorders

Study Officials

  • Eduard Gratacos, PhD

    Hospital Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrics Department Head Hospital Clinic Barcelona

Study Record Dates

First Submitted

August 1, 2016

First Posted

September 20, 2016

Study Start

May 4, 2016

Primary Completion

January 6, 2022

Study Completion

January 6, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)ES(3)IL(1)PL(1)CL(1)CZ(2)