RESUMEN
BACKGROUND: Fetal smallness affects 10% of pregnancies. Small fetuses are at a higher risk of adverse outcomes. Their management using estimated fetal weight and feto-maternal Doppler has a high sensitivity for adverse outcomes; however, more than 60% of fetuses are electively delivered at 37 to 38 weeks. On the other hand, classification using angiogenic factors seems to have a lower false-positive rate. Here, we present a protocol for the Fetal Growth Restriction at Term Managed by Angiogenic Factors Versus Feto-Maternal Doppler (GRAFD) trial, which compares the use of angiogenic factors and Doppler to manage small fetuses at term. OBJECTIVE: The primary objective is to demonstrate that classification based on angiogenic factors is not inferior to estimated fetal weight and Doppler at detecting fetuses at risk of adverse perinatal outcomes. METHODS: This is a multicenter, open-label, randomized controlled trial conducted in 20 hospitals across Spain. A total of 1030 singleton pregnancies with an estimated fetal weight ≤10th percentile at 36+0 to 37+6 weeks+days will be recruited and randomly allocated to either the control or the intervention group. In the control group, standard Doppler-based management will be used. In the intervention group, cases with a soluble fms-like tyrosine kinase to placental growth factor ratio ≥38 will be classified as having fetal growth restriction; otherwise, they will be classified as being small for gestational age. In both arms, the fetal growth restriction group will be delivered at ≥37 weeks and the small for gestational age group at ≥40 weeks. We will assess differences between the groups by calculating the relative risk, the absolute difference between incidences, and their 95% CIs. RESULTS: Recruitment for this study started on September 28, 2020. The study results are expected to be published in peer-reviewed journals and disseminated at international conferences in early 2023. CONCLUSIONS: The angiogenic factor-based protocol may reduce the number of pregnancies classified as having fetal growth restriction without worsening perinatal outcomes. Moreover, reducing the number of unnecessary labor inductions would reduce costs and the risks derived from possible iatrogenic complications. Additionally, fewer inductions would lower the rate of early-term neonates, thus improving neonatal outcomes and potentially reducing long-term infant morbidities. TRIAL REGISTRATION: ClinicalTrials.gov NCT04502823; https://clinicaltrials.gov/ct2/show/NCT04502823. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37452.
RESUMEN
OBJECTIVE: To compare cardiac biometry and function between fetuses with and without intracardiac echogenic foci (ICEF). METHODS: One hundred and fifty-two fetuses with ICEF were compared with 104 controls. Diastolic ventricular transverse diameters, systolic aortic and pulmonary diameters and interventricular septum were measured. Doppler measurements included pulmonary artery and aortic maximum systolic velocities, time to peak, velocity time integral and atrioventricular E/A ratios. RESULTS: Only A wave in the mitral valve was slightly but significantly higher in the ICEF group (0.45 ± 0.07 m/s vs 0.43 ± 0.08 m/s, p = 0.03), but mitral E/A ratio was similar in both groups (0.61 ± 0.06 vs 0.60 ± 0.07, p = 0.22). There were no statistically significant differences in the rest of the studied variables between the two groups. CONCLUSION: Fetuses with ICEF do not have relevant abnormalities in either cardiac biometry or function. We suggest the presence of an isolated ICEF should not be an indication for fetal echocardiography as long as fetal morphology scan had been performed and revealed no other findings.
