Term Planned Delivery Based on Fetal Growth Assessment With or Without the Cerebroplacental Ratio in Low-Risk Pregnancies (RATIO37): An International, Multicentre, Open-Label, Randomized Controlled Trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00098892%3A_____%2F24%3A10158731" target="_blank" >RIV/00098892:_____/24:10158731 - isvavai.cz</a>

Výsledek na webu

<a href="https://journals.lww.com/obgynsurvey/abstract/2024/08000/term_planned_delivery_based_on_fetal_growth.2.aspx" target="_blank" >https://journals.lww.com/obgynsurvey/abstract/2024/08000/term_planned_delivery_based_on_fetal_growth.2.aspx</a>

DOI - Digital Object Identifier

—

Jazyk výsledku

angličtina

Název v původním jazyce

Term Planned Delivery Based on Fetal Growth Assessment With or Without the Cerebroplacental Ratio in Low-Risk Pregnancies (RATIO37): An International, Multicentre, Open-Label, Randomized Controlled Trial

Popis výsledku v původním jazyce

Up to 3% of term pregnancies result in adverse perinatal outcomes, often caused by placental insufficiency. Detecting placental insufficiency can facilitate the prevention of adverse perinatal outcomes. One current tool for detecting placental insufficiency is obtaining an estimated fetal weight by ultrasound and identifying those that are small for gestational age (SGA), defined as an estimated fetal weight below the 10th percentile. However, this threshold fails to detect about two-thirds of stillbirths and severe neonatal complications secondary to hypoxia. Another potential tool is the Doppler cerebroplacental ratio (CPR), which detects the presence of fetal brain vasodilation secondary to hypoxia. The CPR is calculated by measuring the middle cerebral artery pulsatility index and dividing it by the umbilical artery pulsatility index. Studies have found that a low CPR is associated with a 3.7-fold increased risk of perinatal mortality and long-term neurological outcomes in suspected SGA fetuses. Other studies have found an association between the CPR value and perinatal mortality and neonatal morbidity, independent of birth weight. However, there have been no randomized trials that have assessed the use of the CPR to improve low-risk, obstetric outcomes. The aim of this study was to assess whether adding CPR measurement to the standard ultrasound growth assessment reduces stillbirths and severe neonatal morbidity versus a fetal growth assessment alone. This was a randomized, open-label, pragmatic trial conducted at 9 hospitals in Chile, the Czech Republic, Israel, Mexico, Poland, and Spain between 2016, and 2021. Included were low-risk singleton pregnancies in the first trimester with a viable fetus with no congenital malformations at routine ultrasound in the second trimester. Excluded were those with adverse medical or obstetric history, fetal congenital malformations, congenital infections, and obstetric complications requiring delivery before 37 weeks of gestation. Participants were randomly assigned at a 1:1 ratio to a concealed or a revealed group. In the concealed group, clinicians were blinded to the CPR value; in the revealed group, clinicians knew the value and could use it for clinical management. All participants underwent ultrasound between 36 and 37 ± 6 weeks along with a fetal growth assessment and Doppler evaluation. Only in the revealed group was the CPR known and used to schedule induction of labor at 37 weeks’ gestation if less than the fifth percentile. The primary outcome was perinatal mortality from 24 weeks to infant discharge. Secondary outcomes included severe neurological morbidity, severe nonneurological morbidity with cardiac failure, and fetal birth weight less than the third percentile. Three post hoc analyses were conducted for overall severe neonatal morbidity, CPR less than the fifth percentile in women with complete data, and frequency of predefined outcomes based on the CPR in the concealed group. A total of 9492 women were included in the analysis, with 4774 in the concealed group and 4718 in the revealed group. Perinatal mortality occurred in 0.3% and 0.3% of pregnancies in each group (odds ratio [OR], 1.45; 95% confidence interval [CI], 0.72–2.76; P = 0.262). No differences in severe neurologic morbidity were found between the 2 groups (OR, 0.56; 95% CI, 0.25–1.24; P = 0.153). However, significant differences in severe nonneurological morbidity were observed (0.48% in the concealed group vs 0.19% in the revealed group; OR, 0.58; 95% CI, 0.39–0.87; P = 0.0086). Overall, there was a reduction of severe neurological and nonneurological neonatal morbidity between the groups (OR, 0.58; 95% CI, 0.40–0.83; P = 0.0033). Cases with a CPR of less than the fifth percentile were more likely to have a nonneurological adverse outcome (OR, 6.2; 95% CI, 2.5–15.2), overall severe outcome (OR, 4.2; 95% CI, 1.9–9.3), birth weight less than the 10th percentile (OR, 4.3, 95% CI, 3.1–6.0), and birth weight less than the third percentile (OR, 4.5, 95% CI, 2.4–8.7). In conclusion, adding the CPR to routine growth assessment by ultrasound did not reduce perinatal mortality. However, it did reduce severe neonatal morbidity compared with ultrasound alone.

Název v anglickém jazyce

Term Planned Delivery Based on Fetal Growth Assessment With or Without the Cerebroplacental Ratio in Low-Risk Pregnancies (RATIO37): An International, Multicentre, Open-Label, Randomized Controlled Trial

Popis výsledku anglicky

Up to 3% of term pregnancies result in adverse perinatal outcomes, often caused by placental insufficiency. Detecting placental insufficiency can facilitate the prevention of adverse perinatal outcomes. One current tool for detecting placental insufficiency is obtaining an estimated fetal weight by ultrasound and identifying those that are small for gestational age (SGA), defined as an estimated fetal weight below the 10th percentile. However, this threshold fails to detect about two-thirds of stillbirths and severe neonatal complications secondary to hypoxia. Another potential tool is the Doppler cerebroplacental ratio (CPR), which detects the presence of fetal brain vasodilation secondary to hypoxia. The CPR is calculated by measuring the middle cerebral artery pulsatility index and dividing it by the umbilical artery pulsatility index. Studies have found that a low CPR is associated with a 3.7-fold increased risk of perinatal mortality and long-term neurological outcomes in suspected SGA fetuses. Other studies have found an association between the CPR value and perinatal mortality and neonatal morbidity, independent of birth weight. However, there have been no randomized trials that have assessed the use of the CPR to improve low-risk, obstetric outcomes. The aim of this study was to assess whether adding CPR measurement to the standard ultrasound growth assessment reduces stillbirths and severe neonatal morbidity versus a fetal growth assessment alone. This was a randomized, open-label, pragmatic trial conducted at 9 hospitals in Chile, the Czech Republic, Israel, Mexico, Poland, and Spain between 2016, and 2021. Included were low-risk singleton pregnancies in the first trimester with a viable fetus with no congenital malformations at routine ultrasound in the second trimester. Excluded were those with adverse medical or obstetric history, fetal congenital malformations, congenital infections, and obstetric complications requiring delivery before 37 weeks of gestation. Participants were randomly assigned at a 1:1 ratio to a concealed or a revealed group. In the concealed group, clinicians were blinded to the CPR value; in the revealed group, clinicians knew the value and could use it for clinical management. All participants underwent ultrasound between 36 and 37 ± 6 weeks along with a fetal growth assessment and Doppler evaluation. Only in the revealed group was the CPR known and used to schedule induction of labor at 37 weeks’ gestation if less than the fifth percentile. The primary outcome was perinatal mortality from 24 weeks to infant discharge. Secondary outcomes included severe neurological morbidity, severe nonneurological morbidity with cardiac failure, and fetal birth weight less than the third percentile. Three post hoc analyses were conducted for overall severe neonatal morbidity, CPR less than the fifth percentile in women with complete data, and frequency of predefined outcomes based on the CPR in the concealed group. A total of 9492 women were included in the analysis, with 4774 in the concealed group and 4718 in the revealed group. Perinatal mortality occurred in 0.3% and 0.3% of pregnancies in each group (odds ratio [OR], 1.45; 95% confidence interval [CI], 0.72–2.76; P = 0.262). No differences in severe neurologic morbidity were found between the 2 groups (OR, 0.56; 95% CI, 0.25–1.24; P = 0.153). However, significant differences in severe nonneurological morbidity were observed (0.48% in the concealed group vs 0.19% in the revealed group; OR, 0.58; 95% CI, 0.39–0.87; P = 0.0086). Overall, there was a reduction of severe neurological and nonneurological neonatal morbidity between the groups (OR, 0.58; 95% CI, 0.40–0.83; P = 0.0033). Cases with a CPR of less than the fifth percentile were more likely to have a nonneurological adverse outcome (OR, 6.2; 95% CI, 2.5–15.2), overall severe outcome (OR, 4.2; 95% CI, 1.9–9.3), birth weight less than the 10th percentile (OR, 4.3, 95% CI, 3.1–6.0), and birth weight less than the third percentile (OR, 4.5, 95% CI, 2.4–8.7). In conclusion, adding the CPR to routine growth assessment by ultrasound did not reduce perinatal mortality. However, it did reduce severe neonatal morbidity compared with ultrasound alone.

Druh

O - Ostatní výsledky

CEP obor

—

OECD FORD obor

30214 - Obstetrics and gynaecology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2024

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů