Revealed Versus Concealed Cerebroplacental Ratio

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-04

Study Completion Date

2022-01-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stillbirth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Concealment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Revealment

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

Group Type OTHER

Revealment

Intervention Type OTHER

Cerebroplacental ratio revealment

Interventions

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Revealment

Cerebroplacental ratio revealment

Intervention Type OTHER

Eligibility Criteria

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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