An interventional study of Revealment in Stillbirth, sponsored by Hospital Clinic of Barcelona. Completed at 9 sites in 6 countries. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-18.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Prevention
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.
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
117 studies on the registry are indexed under Stillbirth; 33 are open to participants now.
This study's enrollment of 11,582 is above the median of 275 across 66 interventional studies indexed under Stillbirth.
Browse Stillbirth studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cerebroplacental ratio measurement at 37 weeks of pregnancy only taken into account if estimated fetal weight \<p10
Cerebroplacental ratio measurement at 37weeks and labor induction in case of cerebroplacental ratio \<p5
Other: Revealment
Cerebroplacental ratio revealment
Stillbirth
Perinatal death
Time frame: between 37 and 42 weeks of pregnancy
Adverse perinatal outcome
Severe neurological and non-neurological adverse outcome
Time frame: Up to 28 days after delivery
Fetal Growth Restriction Detection
To detect prenatal low birth weight
Time frame: 3 years
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Hospital Clinic of Barcelona