Clinical trial NCT02907242: Revealed Versus Concealed Cerebroplacental Ratio
Official title: Revealed Versus Concealed Criteria for Placental Insufficiency in Unselected Obstetric Population in Late Pregnancy: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stillbirth
Keywords: stillbirth
cerebroplacental ratio
fetal growth restriction
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 11582
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stillbirth
timeFrame: between 37 and 42 weeks of pregnancy
Secondary outcomes:
measure: Adverse perinatal outcome
timeFrame: Up to 28 days after delivery
measure: Fetal Growth Restriction Detection
timeFrame: 3 years
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Hospital Clínico Universitario de Santiago de Chile
city: Olomouc
country: Czechia
facility: Palacky University Hospital
city: Prague
country: Czechia
facility: Ladislav Krofta
city: Tel Aviv
country: Israel
facility: Eyal Zohav
city: Querétaro
country: Mexico
facility: Hospital de Querétaro
city: Warsaw
country: Poland
facility: Anna Kajdy
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Elena Escazzocchio
city: Barcelona
country: Spain
facility: Elena Ferriols Perez
Study officials:
affiliation: Hospital Clinic
name: Eduard Gratacos, PhD
role: STUDY_CHAIR
References:
citation: 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.