Term planned delivery based on fetal growth assessment with or without the cerebroplacental ratio in low-risk pregnancies (RATIO37): an international, multicentre, openlabel, randomised controlled trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023698%3A_____%2F24%3AN0000022" target="_blank" >RIV/00023698:_____/24:N0000022 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11120/24:43926533 RIV/00216208:11150/24:10473856 RIV/00179906:_____/24:10473856 RIV/00098892:_____/24:10158627

Výsledek na webu

<a href="https://pubmed.ncbi.nlm.nih.gov/38219773/" target="_blank" >https://pubmed.ncbi.nlm.nih.gov/38219773/</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S0140-6736(23)02228-6" target="_blank" >10.1016/S0140-6736(23)02228-6</a>

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, openlabel, randomised controlled trial

Popis výsledku v původním jazyce

Background The cerebroplacental ratio is associated with perinatal mortality and morbidity, but it is unknown whether routine measurement improves pregnancy outcomes. We aimed to evaluate whether the addition of cerebroplacental ratio measurement to the standard ultrasound growth assessment near term reduces perinatal mortality and severe neonatal morbidity, compared with growth assessment alone. Methods RATIO37 was a randomised, open -label, multicentre, pragmatic trial, conducted in low-risk pregnant women, recruited from nine hospitals over six countries. The eligibility criteria were designed to be broad; participants were required to be 18 years or older, with an ultrasound-dated confirmed singleton pregnancy in the first trimester, an alive fetus with no congenital malformations at the routine second -trimester ultrasound, an absence of adverse medical or obstetric history, and the capacity to give informed consent. Women were randomly assigned in a 1:1 ratio (block size 100) using a web-based system to either the concealed group or revealed group. In the revealed group, the cerebroplacental ratio value was known by clinicians, and if below the fifth centile, a planned delivery after 37 weeks was recommended. In the concealed group, women and clinicians were blinded to the cerebroplacental ratio value. All participants underwent ultrasound at 36 + 0 to 37 + 6 weeks of gestation with growth assessment and Doppler evaluation. In both groups, planned delivery was recommended when the estimated fetal weight was below the tenth centile. The primary outcome was perinatal mortality from 24 weeks' gestation to infant discharge. The study is registered at ClinicalTrials.gov (NCT02907242) and is now closed. Findings Between July 29, 2016, and Aug 3, 2021, we enrolled 11 214 women, of whom 9492 (84 center dot 6%) completed the trial and were eligible for analysis (4774 in the concealed group and 4718 in the revealed group). Perinatal mortality occurred in 13 (0 center dot 3%) of 4774 pregnancies in the concealed group and 13 (0 center dot 3%) of 4718 in the revealed group (OR 1 center dot 45 [95% CI 0 center dot 76-2 center dot 76]; p=0 center dot 262). Overall, severe neonatal morbidity occurred in 35 (0 center dot 73%) newborns in the concealed group and 18 (0 center dot 38%) in the revealed group (OR 0 center dot 58 [95% CI 0 center dot 40-0 center dot 83]; p=0 center dot 003). Severe neurological morbidity occurred in 13 (0 center dot 27%) newborns in the concealed group and nine (0 center dot 19%) in the revealed group (OR 0 center dot 56 [95% CI 0 center dot 25-1 center dot 24]; p=0 center dot 153). Severe non-neurological morbidity occurred in 23 (0 center dot 48%) newborns in the concealed group and nine (0 center dot 19%) in the revealed group (0 center dot 58 [95% CI 0 center dot 39-0 center dot 87]; p=0 center dot 009). Maternal adverse events were not collected. Interpretation Planned delivery at term based on ultrasound fetal growth assessment and cerebroplacental ratio at term was not followed by a reduction of perinatal mortality although significantly reduced severe neonatal morbidity compared with fetal growth assessment 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, openlabel, randomised controlled trial

Popis výsledku anglicky

Background The cerebroplacental ratio is associated with perinatal mortality and morbidity, but it is unknown whether routine measurement improves pregnancy outcomes. We aimed to evaluate whether the addition of cerebroplacental ratio measurement to the standard ultrasound growth assessment near term reduces perinatal mortality and severe neonatal morbidity, compared with growth assessment alone. Methods RATIO37 was a randomised, open -label, multicentre, pragmatic trial, conducted in low-risk pregnant women, recruited from nine hospitals over six countries. The eligibility criteria were designed to be broad; participants were required to be 18 years or older, with an ultrasound-dated confirmed singleton pregnancy in the first trimester, an alive fetus with no congenital malformations at the routine second -trimester ultrasound, an absence of adverse medical or obstetric history, and the capacity to give informed consent. Women were randomly assigned in a 1:1 ratio (block size 100) using a web-based system to either the concealed group or revealed group. In the revealed group, the cerebroplacental ratio value was known by clinicians, and if below the fifth centile, a planned delivery after 37 weeks was recommended. In the concealed group, women and clinicians were blinded to the cerebroplacental ratio value. All participants underwent ultrasound at 36 + 0 to 37 + 6 weeks of gestation with growth assessment and Doppler evaluation. In both groups, planned delivery was recommended when the estimated fetal weight was below the tenth centile. The primary outcome was perinatal mortality from 24 weeks' gestation to infant discharge. The study is registered at ClinicalTrials.gov (NCT02907242) and is now closed. Findings Between July 29, 2016, and Aug 3, 2021, we enrolled 11 214 women, of whom 9492 (84 center dot 6%) completed the trial and were eligible for analysis (4774 in the concealed group and 4718 in the revealed group). Perinatal mortality occurred in 13 (0 center dot 3%) of 4774 pregnancies in the concealed group and 13 (0 center dot 3%) of 4718 in the revealed group (OR 1 center dot 45 [95% CI 0 center dot 76-2 center dot 76]; p=0 center dot 262). Overall, severe neonatal morbidity occurred in 35 (0 center dot 73%) newborns in the concealed group and 18 (0 center dot 38%) in the revealed group (OR 0 center dot 58 [95% CI 0 center dot 40-0 center dot 83]; p=0 center dot 003). Severe neurological morbidity occurred in 13 (0 center dot 27%) newborns in the concealed group and nine (0 center dot 19%) in the revealed group (OR 0 center dot 56 [95% CI 0 center dot 25-1 center dot 24]; p=0 center dot 153). Severe non-neurological morbidity occurred in 23 (0 center dot 48%) newborns in the concealed group and nine (0 center dot 19%) in the revealed group (0 center dot 58 [95% CI 0 center dot 39-0 center dot 87]; p=0 center dot 009). Maternal adverse events were not collected. Interpretation Planned delivery at term based on ultrasound fetal growth assessment and cerebroplacental ratio at term was not followed by a reduction of perinatal mortality although significantly reduced severe neonatal morbidity compared with fetal growth assessment alone.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30214 - Obstetrics and gynaecology

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2024

Kód důvěrnosti údajů

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

Název periodika

LANCET

ISSN

0140-6736

e-ISSN

1474-547X

Svazek periodika

403

Číslo periodika v rámci svazku

10426

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

545-553

Kód UT WoS článku

001184461300001

EID výsledku v databázi Scopus

2-s2.0-85182363219