Revealed Versus Concealed Cerebroplacental Ratio

Stillbirth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907242
• Other study ID #: RATIO37
• Status: Completed
• Phase: N/A
• Start date: May 4, 2016
• Est. completion date: January 6, 2022

Study information

• Verified date: April 2022
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11582
• Est. completion date: January 6, 2022
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Stillbirth

Intervention

Other:
• Revealment
Cerebroplacental ratio revealment

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Countries where clinical trial is conducted

Chile,  Czechia,  Israel,  Mexico,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stillbirth	Perinatal death	between 37 and 42 weeks of pregnancy
Secondary	Adverse perinatal outcome	Severe neurological and non-neurological adverse outcome	Up to 28 days after delivery
Secondary	Fetal Growth Restriction Detection	To detect prenatal low birth weight	3 years