Revealed Versus Concealed Cerebroplacental Ratio

Not Applicable

Completed

• Conditions: Stillbirth
• Interventions: Other: Revealment

• Registration Number: NCT02907242
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2016-05-04
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Primary Completion: 2022-01-06
• Study Completion: 2022-01-06
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11582

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Stillbirth	between 37 and 42 weeks of pregnancy	Perinatal death

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Palacky University Hospital; 🇨🇿 Olomouc, Czechia

Anna Kajdy; 🇵🇱 Warsaw, Poland

Hospital Clínico Universitario de Santiago de Chile; 🇨🇱 Santiago de Chile, Chile

Hospital de Querétaro; 🇲🇽 Querétaro, Mexico

Eyal Zohav; 🇮🇱 Tel Aviv, Israel

Ladislav Krofta; 🇨🇿 Prague, Czechia

Elena Ferriols Perez; 🇪🇸 Barcelona, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Elena Escazzocchio; 🇪🇸 Barcelona, Spain