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Revealed Versus Concealed Cerebroplacental Ratio

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Francesc Figueras, 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.

Condition or disease Intervention/treatment Phase
Stillbirth Other: Revealment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11582 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stillbirth

Arm Intervention/treatment
No Intervention: Concealment
Cerebroplacental ratio measurement at 37 weeks of pregnancy only taken into account if estimated fetal weight <p10
Revealment
Cerebroplacental ratio measurement at 37weeks and labor induction in case of cerebroplacental ratio <p5
Other: Revealment
Cerebroplacental ratio revealment




Primary Outcome Measures :
  1. Stillbirth [ Time Frame: between 37 and 42 weeks of pregnancy ]

Secondary Outcome Measures :
  1. Adverse perinatal outcome [ Time Frame: Up to 28 days after delivery ]
  2. Fetal Growth Restriction Detection [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Francesc Figueras, PhD 0034932279946 ffiguera@clinic.cat
Contact: Marta Rial, MD 0034932279946 mrial@clinic.cat

Locations
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Chile
Hospital Clínico Universitario de Santiago de Chile Active, not recruiting
Santiago de Chile, Chile
Czech Republic
Palacky University Hospital Recruiting
Olomouc, Czech Republic
Contact: Marek Lubusky, PhD       marek@lubusky.com   
Mexico
Hospital de Querétaro Not yet recruiting
Querétaro, Mexico
Contact: Rogelio Cruz, PhD       cruz-martinezr@hotmail.com   
Spain
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Marta Rial, MD    0034932279946    mrial@clinic.cat   
Contact: Francesc Figueras, PhD    00342279946    ffiguera@clinic.cat   
Sub-Investigator: Eduard Gratacos, PhD         
Switzerland
Hopitaux Universitaires de Geneve Not yet recruiting
Geneve, Switzerland
Contact: Begoña Martinez, PhD       Begona.MartinezDeTejada@hcuge.ch   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Study Chair: Eduard Gratacos, PhD Hospital Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francesc Figueras, Obstetrics Department Head Hospital Clinic Barcelona, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02907242    
Other Study ID Numbers: RATIO37
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Francesc Figueras, Hospital Clinic of Barcelona:
stillbirth
cerebroplacental ratio
fetal growth restriction
Additional relevant MeSH terms:
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Stillbirth
Fetal Death
Pregnancy Complications
Death
Pathologic Processes