Revealed Versus Concealed Cerebroplacental Ratio
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|ClinicalTrials.gov Identifier: NCT02907242|
Recruitment Status : Unknown
Verified September 2016 by Francesc Figueras, Hospital Clinic of Barcelona.
Recruitment status was: Recruiting
First Posted : September 20, 2016
Last Update Posted : September 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stillbirth||Other: Revealment||Not Applicable|
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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||11582 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Revealed Versus Concealed Criteria for Placental Insufficiency in Unselected Obstetric Population in Late Pregnancy: a Multicenter Randomized Controlled Trial|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||January 2019|
No Intervention: Concealment
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
Cerebroplacental ratio revealment
- Stillbirth [ Time Frame: between 37 and 42 weeks of pregnancy ]
- Adverse perinatal outcome [ Time Frame: Up to 28 days after delivery ]
- Fetal Growth Restriction Detection [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907242
|Contact: Francesc Figueras, PhDfirstname.lastname@example.org|
|Contact: Marta Rial, MDemail@example.com|
|Hospital Clínico Universitario de Santiago de Chile||Active, not recruiting|
|Santiago de Chile, Chile|
|Palacky University Hospital||Recruiting|
|Olomouc, Czech Republic|
|Contact: Marek Lubusky, PhD firstname.lastname@example.org|
|Hospital de Querétaro||Not yet recruiting|
|Contact: Rogelio Cruz, PhD email@example.com|
|Barcelona, Spain, 08036|
|Contact: Marta Rial, MD 0034932279946 firstname.lastname@example.org|
|Contact: Francesc Figueras, PhD 00342279946 email@example.com|
|Sub-Investigator: Eduard Gratacos, PhD|
|Hopitaux Universitaires de Geneve||Not yet recruiting|
|Contact: Begoña Martinez, PhD Begona.MartinezDeTejada@hcuge.ch|
|Study Chair:||Eduard Gratacos, PhD||Hospital Clinic|