RELAIS: Third Trimester Screening of Fetal Growth Restriction
Study Details
Study Description
Brief Summary
The aim of this trial is to assess the efficacy and efficiency of the national and the research sonographic screening protocols for fetal growth disorders.
In particular, in Italy at the moment we have two different national screening protocols: the traditional one providing an early third trimester scan at 28-32 weeks'gestation, and a more recent one, according to the new LEA (livelli essenziali di assistenza), providing a growth scan during the third trimester only if there is a clinical indication. Both these national protocols will be compared to a research protocol providing a late third trimester scan between 35 and 37 weeks'gestation in terms of sensibility and specificity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
In Italy, the universal sonographic third trimester screening based on a third scan at 28-32 weeks of gestation failed its original aim to screen IUGR fetuses. Except for the very few early severe cases of IUGR that occur before 28 weeks of gestation (approximately 0.2%), the vast majority of fetal growth disorders occur later in gestation and are frequently missed by the early third trimester scan at 28-32 weeks of gestation.
As a result of clinical uncertainties many ultrasound examinations are then performed on the ground of "clinical indication" (m50 prescriptions). According to the Cedap report for the year 2014, 41% of all pregnancies undergo four to six obstetrical sonographic examinations and 32% more than seven! An even worse, unwanted result of the italian protocol is that "normal" scans at 30 weeks of gestation falsely reassure the clinician that might underestimate fetal growth restriction in late preterm or term pregnancies, with unexpected poor obstetrical outcomes in labor and delivery.
This failure puts the ground of the idea of uselessness of this early third trimester sonographic fetal growth checkpoint and the need of its cancellation.
This study is designed to generate level 1 evidence of diagnostic efficacy. MAIN OUTCOME: The main outcome of the two protocols in screening true late preterm and term SGA fetuses is measured based Italian newborn weight charts centiles <the 10th according to gestational age and gender at delivery.
SECONDARY OUTCOME
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The screen positive and screen negative results for the two protocols Early-TT, and Late-TT are based only on AC biometry and/or fetal weight <10th centile or crossing 50th centiles at scheduled exams, for the protocol TT-Indication are based on results at first medical indication.
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Mode of delivery
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Caesarean section rate according to Robson classes for singleton
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Composite mild adverse neonatal outcome (Apgar score at 5 minutes <7, pH < 7.10, or BD
8mmol/L, admission at NICU)
- Composite severe adverse perinatal (stillbirth or term live birth associated with neonatal death, hypoxic ischaemic encephalopathy, use of inotropes, need for mechanical ventilation, or severe metabolic acidosis (defined as a cord blood pH <7•0 and base deficit >12 mmol/L)
TERTIARY OUTCOME
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Number of ultrasound scans performed in outpatient clinics by medical indication (SSR-prescription) beyond Early-TT and late-TT scheduled exams, and number of ultrasound scans performed on indication in outpatient clinics minus the first one indicated.
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Number of ultrasound scans by patient choice
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Econometrics of the two protocols, and of the estimated sanitary costs of outcomes
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Single scan Normal screening at 28-32 weeks as currently recommended |
Other: Third trimester ultrasound
Third Trimester U/S on indication (TT-Indication) vs Late Third Trimester Protocol (Late-TT)(Trial n°2).
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| Experimental: Longitudinal scan Early and late ultrasound screening with a scan at 35-37 weeks to detect late iugr |
Other: Third trimester ultrasound
Third Trimester U/S on indication (TT-Indication) vs Late Third Trimester Protocol (Late-TT)(Trial n°2).
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Outcome Measures
Primary Outcome Measures
- sensitivity [1 year]
screening performance
Secondary Outcome Measures
- Percentage of delivery [1 year]
spontaneous versus c section on late fgr
- percentage of C section [1 year]
C section rate according to Robson classes for singleton
- number of advers outcome [up to 40 days after birth]
neonatal ossigenation and ph Composite severe adverse perinatal (stillbirth or term live birth associated with neonatal death, hypoxic ischaemic encephalopathy, use of inotropes, need for mechanical ventilation, or severe metabolic acidosis (defined as a cord blood pH <7•0 and base deficit >12 mmol/L)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Eligible cases are nulliparous pregnant women, with first trimester ultrasound assessment of gestational age, who conceived singleton fetuses. If the crown-rump-length (CRL) differs of more than ± 3-5 days from the last menstrual period, gestational age is calculated on the CRL.
Exclusion Criteria:
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major medical disease
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high risk for preeclampsia on history or detected in those centres that perform pre-eclampsia screening at first trimester
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women older than 40 years on ASA low dose prophylaxis
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known immune disorders or clinical thrombophilic conditions;
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twin pregnancies;
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ovodonations
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suspected fetal anomalies at any gestational age
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Papp-A at Combined-Test<0.2
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | FP Gemelli IRCCS | Rome | RM | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1909