Revealed Versus Concealed Cerebroplacental Ratio

Hospital Clinic of Barcelona

Status: Completed

Conditions: Stillbirth

Treatments: Other: Revealment

Study type: Interventional

Funder types: Other

Identifiers

NCT02907242

RATIO37

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,582 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11,582 participants in 2 patient groups

Concealment

No Intervention group

Description:

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

Revealment

Other group

Description:

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

Treatment:

Other: Revealment