StillbirthNCT02907242
Revealed Versus Concealed Cerebroplacental Ratio
A study testing Revealment in people with Stillbirth, run by Hospital Clinic of Barcelona at 9 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stillbirth
- What is being tested?
- Revealment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,582 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 4 May 2016to 6 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Abnormal karyotype
- Structural abnormalities
- Congenital infections
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Spain3 sites
Hospital Clinic
Barcelona, 08036
Elena Escazzocchio
Barcelona
Elena Ferriols Perez
Barcelona
About this study
Official title: Revealed Versus Concealed Criteria for Placental Insufficiency in Unselected Obstetric Population in Late Pregnancy: a Multicenter Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Stillbirth
- Being tested
- Revealment
- Keywords
- stillbirth, cerebroplacental ratio, fetal growth restriction
- Medical subject headings
- Stillbirth, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevealmentOther
Cerebroplacental ratio revealment
| Study group | Role | What they receive |
|---|---|---|
| Concealment | No intervention | Cerebroplacental ratio measurement at 37 weeks of pregnancy only taken into account if estimated fetal weight <p10 |
| Revealment | Other | Cerebroplacental ratio measurement at 37weeks and labor induction in case of cerebroplacental ratio <p5 Receives: Other: Revealment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stillbirth
Perinatal death
Measured: between 37 and 42 weeks of pregnancy
Secondary outcomes (2)
Adverse perinatal outcome
Severe neurological and non-neurological adverse outcome
Measured: Up to 28 days after delivery
Fetal Growth Restriction Detection
To detect prenatal low birth weight
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start4 May 2016
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11,582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesc Figueras, Hospital Clinic of Barcelona
- Investigators
- Eduard Gratacos, PhD, Study chair, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907242
- Sponsor's protocol ID
- RATIO37
- Status last verified
- Apr 2022
- First submitted
- 1 Aug 2016
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rial-Crestelo M, Lubusky M, Parra-Cordero M, Krofta L, Kajdy A, Zohav E, Ferriols-Perez E, Cruz-Martinez R, Kacerovsky M, Scazzocchio E, Roubalova L, Socias P, Haslik L, Modzelewski J, Ashwal E, Castella-Cesari J, Cruz-Lemini M, Gratacos E, Figueras F; RATIO37 Study Group. Term planned delivery based on fetal growth assessment with or without the cerebroplacental ratio in low-risk pregnancies (RATIO37): an international, multicentre, open-label, randomised controlled trial. Lancet. 2024 Feb 10;403(10426):545-553. doi: 10.1016/S0140-6736(23)02228-6. Epub 2024 Jan 11.
PubMed 38219773Figueras F, Gratacos E, Rial M, Gull I, Krofta L, Lubusky M, Cruz-Martinez R, Cruz-Lemini M, Martinez-Rodriguez M, Socias P, Aleuanlli C, Cordero MCP. Revealed versus concealed criteria for placental insufficiency in an unselected obstetric population in late pregnancy (RATIO37): randomised controlled trial study protocol. BMJ Open. 2017 Jun 15;7(6):e014835. doi: 10.1136/bmjopen-2016-014835.
PubMed 28619771
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revealed Versus Concealed Criteria for Placental Insufficiency in Unselected Obstetric Population in Late Pregnancy: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02907242
- Acronym / sponsor ID
- RATIO37
- Conditions
- Stillbirth
- Keywords
- stillbirth, cerebroplacental ratio, fetal growth restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,582 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 4 May 2016 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concealment | No intervention | –Cerebroplacental ratio measurement at 37 weeks of pregnancy only taken into account if estimated fetal weight <p10 |
| Revealment | Other | Other: RevealmentCerebroplacental ratio measurement at 37weeks and labor induction in case of cerebroplacental ratio <p5 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Abnormal karyotype
- Structural abnormalities
- Congenital infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevealmentCerebroplacental ratio revealment | Other | Revealment |
Primary outcome
Stillbirth
Time frame: between 37 and 42 weeks of pregnancy
Perinatal death
2 secondary outcomes
Adverse perinatal outcome
Time frame: Up to 28 days after delivery
Fetal Growth Restriction Detection
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Derived from this study: PubMed 38219773Rial-Crestelo M, Lubusky M, Parra-Cordero M, Krofta L, Kajdy A, Zohav E, Ferriols-Perez E, Cruz-Martinez R, Kacerovsky M, Scazzocchio E, Roubalova L, Socias P, Haslik L, Modzelewski J, Ashwal E, Castella-Cesari J, Cruz-Lemini M, Gratacos E, Figueras F; RATIO37 Study Group. Term planned delivery based on fetal growth assessment with or without the cerebroplacental ratio in low-risk pregnancies (RATIO37): an international, multicentre, open-label, randomised controlled trial. Lancet. 2024 Feb 10;403(10426):545-553. doi: 10.1016/S0140-6736(23)02228-6. Epub 2024 Jan 11.
- Derived from this study: PubMed 28619771Figueras F, Gratacos E, Rial M, Gull I, Krofta L, Lubusky M, Cruz-Martinez R, Cruz-Lemini M, Martinez-Rodriguez M, Socias P, Aleuanlli C, Cordero MCP. Revealed versus concealed criteria for placental insufficiency in an unselected obstetric population in late pregnancy (RATIO37): randomised controlled trial study protocol. BMJ Open. 2017 Jun 15;7(6):e014835. doi: 10.1136/bmjopen-2016-014835.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Gratacos, PhD study chair
Hospital Clinic
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revealment in people with Stillbirth, run by Hospital Clinic of Barcelona at 9 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Czechia, Chile, Israel, Mexico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stillbirth (time frame: between 37 and 42 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02907242, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.