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 Title of Study: “Revealed Versus Concealed Criteria for Placental Insufficiency in Unselected Obstetric Population in Late Pregnancy: a Multicenter Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: May 2018
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.
- Other: Revealment
- Cerebroplacental ratio revealment
Arms, Groups and Cohorts
- No Intervention: Concealment
- Cerebroplacental ratio measurement at 37 weeks of pregnancy only taken into account if estimated fetal weight <p10
- Other: Revealment
- Cerebroplacental ratio measurement at 37weeks and labor induction in case of cerebroplacental ratio <p5
Clinical Trial Outcome Measures
- 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
Participating in This Clinical Trial
- 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
- Abnormal karyotype
- Structural abnormalities
- Congenital infections
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Hospital Clinic of Barcelona
- Provider of Information About this Clinical Study
- Principal Investigator: Francesc Figueras, Obstetrics Department Head Hospital Clinic Barcelona – Hospital Clinic of Barcelona
- Overall Official(s)
- Eduard Gratacos, PhD, Study Chair, Hospital Clinic
- Overall Contact(s)
- Francesc Figueras, PhD, 0034932279946, email@example.com
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