دورية أكاديمية

Doppler ultrasound of umbilical and middle cerebral artery in third trimester small-for-gestational age fetuses to decide on timing of delivery for suspected fetal growth restriction: A cohort with nested RCT (DRIGITAT).

التفاصيل البيبلوغرافية
العنوان: Doppler ultrasound of umbilical and middle cerebral artery in third trimester small-for-gestational age fetuses to decide on timing of delivery for suspected fetal growth restriction: A cohort with nested RCT (DRIGITAT).
المؤلفون: Marijnen MC; Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands.; Amsterdam Reproduction & Development Research Institute, Amsterdam, The Netherlands., Kamphof HD; Department of Obstetrics and Gynaecology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Damhuis SE; Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands.; Amsterdam Reproduction & Development Research Institute, Amsterdam, The Netherlands.; Department of Obstetrics and Gynaecology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Smies M; Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands.; Amsterdam Reproduction & Development Research Institute, Amsterdam, The Netherlands., Leemhuis AG; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands., Wolf H; Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands., Gordijn SJ; Department of Obstetrics and Gynaecology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Ganzevoort W; Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands.; Amsterdam Reproduction & Development Research Institute, Amsterdam, The Netherlands.
مؤلفون مشاركون: DRIGITAT Trial Group
المصدر: BJOG : an international journal of obstetrics and gynaecology [BJOG] 2024 Jul; Vol. 131 (8), pp. 1042-1053. Date of Electronic Publication: 2024 Feb 05.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 100935741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1471-0528 (Electronic) Linking ISSN: 14700328 NLM ISO Abbreviation: BJOG Subsets: MEDLINE
أسماء مطبوعة: Publication: : Oxford : Wiley-Blackwell
Original Publication: Oxford [England] : Blackwell Science, [2000]-
مواضيع طبية MeSH: Fetal Growth Retardation*/diagnostic imaging , Infant, Small for Gestational Age* , Umbilical Arteries*/diagnostic imaging , Pregnancy Trimester, Third* , Middle Cerebral Artery*/diagnostic imaging , Ultrasonography, Prenatal* , Ultrasonography, Doppler*, Humans ; Female ; Pregnancy ; Adult ; Infant, Newborn ; Delivery, Obstetric/methods ; Pregnancy Outcome ; Cohort Studies ; Gestational Age
مستخلص: Objective: To assess the association of the umbilicocerebral ratio (UCR) with adverse perinatal outcome in late preterm small-for-gestational age (SGA) fetuses and to investigate the effect on perinatal outcomes of immediate delivery.
Design: Multicentre cohort study with nested randomised controlled trial (RCT).
Setting: Nineteen secondary and tertiary care centres.
Population: Singleton SGA pregnancies (estimated fetal weight [EFW] or fetal abdominal circumference [FAC] <10th centile) from 32 to 36 +6  weeks.
Methods: Women were classified: (1) RCT-eligible: abnormal UCR twice consecutive and EFW below the 3 rd centile at/or below 35 weeks or below the 10 th centile at 36 weeks; (2) abnormal UCR once or intermittent; (3) never abnormal UCR. Consenting RCT-eligible patients were randomised for immediate delivery from 34 weeks or expectant management until 37 weeks.
Main Outcome Measures: A composite adverse perinatal outcome (CAPO), defined as perinatal death, birth asphyxia or major neonatal morbidity.
Results: The cohort consisted of 690 women. The study was halted prematurely for low RCT-inclusion rates (n = 40). In the RCT-eligible group, gestational age at delivery, birthweight and birthweight multiple of the median (MoM) (0.66, 95% confidence interval [CI] 0.59-0.72) were significantly lower and the CAPO (n = 50, 44%, p < 0.05) was more frequent. Among patients randomised for immediate delivery there was a near-significant lower birthweight (p = 0.05) and higher CAPO (p = 0.07). EFW MoM, pre-eclampsia, gestational hypertension and Doppler classification were independently associated with the CAPO (area under the curve 0.71, 95% CI 0.67-0.76).
Conclusions: Perinatal risk was effectively identified by low EFW MoM and UCR. Early delivery of SGA fetuses with an abnormal UCR at 34-36 weeks should only be performed in the context of clinical trials.
(© 2024 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)
References: Damhuis SE, Kamphof HD, Ravelli ACJ, Gordijn SJ, Ganzevoort WJ. Perinatal mortality rate and adverse perinatal outcomes presumably attributable to placental dysfunction in (near) term gestation: a nationwide 5‐year cohort study. PLoS One. 2023;18(5):e0285096.
Burton GJ, Jauniaux E. Pathophysiology of placental‐derived fetal growth restriction. Am J Obstet Gynecol. 2018;218(2S):S745–S761.
De Reu PA, Oosterbaan HP, Smits LJ, Nijhuis JG. Avoidable mortality in small‐for‐gestational‐age children in The Netherlands. J Perinat Med. 2010;38(3):311–318.
Audette MC, Kingdom JC. Screening for fetal growth restriction and placental insufficiency. Semin Fetal Neonatal Med. 2018;23(2):119–125.
Vasak B, Koenen SV, Koster MPH, Hukkelhoven CWPM, Franx A, Hanson MA, et al. Human fetal growth is constrained below optimal for perinatal survival. Ultrasound Obstet Gynecol. 2015;45:162–167.
Gordijn SJ, Ganzevoort W. Search for the best prediction model, definition and growth charts for fetal growth restriction using a composite of adverse perinatal outcomes: a catch‐22? Ultrasound Obstet Gynecol. 2022;60(3):305–306.
Society for Maternal‐Fetal Medicine, Martins JG, Biggio JR, Abuhamad A. Society for Maternal‐Fetal Medicine Consult Series #52: diagnosis and management of fetal growth restriction: (Replaces Clinical Guideline Number 3, April 2012). Am J Obstet Gynecol. 2020;223(4):B2–B17.
Beune IM, Pels A, Gordijn SJ, Ganzevoort W. Temporal variation in definition of fetal growth restriction in the literature. Ultrasound Obstet Gynecol. 2019;53:569–570.
Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, et al. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound Obstet Gynecol. 2016;48(3):333–339.
Flood K, Unterscheider J, Daly S, Geary MP, Kennelly MM, McAuliffe FM, et al. The role of brain sparing in the prediction of adverse outcomes in intrauterine growth restriction: results of the multicenter PORTO Study. Am J Obstet Gynecol. 2014;211(3):288.e1–288.e5.
Stampalija T, Thornton J, Marlow N, Napolitano R, Bhide A, Pickles T, et al. Fetal cerebral Doppler changes and outcome in late preterm fetal growth restriction: prospective cohort study. Ultrasound Obstet Gynecol. 2020;56:173–181.
Vollgraff Heidweiller‐Schreurs CA, De Boer MA, Heymans MW, Schoonmade LJ, Bossuyt PMM, Mol BWJ, et al. Prognostic accuracy of cerebroplacental ratio and middle cerebral artery Doppler for adverse perinatal outcome: systematic review and meta‐analysis. Ultrasound Obstet Gynecol. 2018;51:313–322.
Rep A, Ganzevoort W, Van Wassenaer AG, Bonsel GJ, Wolf H, De Vries JI, et al. One‐year infant outcome in women with early‐onset hypertensive disorders of pregnancy. BJOG. 2008;115(2):290–298.
Beukers F, Aarnoudse‐Moens CSH, van Weissenbruch MM, Ganzevoort W, van Goudoever JB, van Wassenaer‐Leemhuis AG. Fetal growth restriction with brain sparing: neurocognitive and behavioral outcomes at 12 years of age. J Pediatr. 2017;188:103–109.e2.
Rana S, Powe CE, Salahuddin S, Verlohren S, Perschel FH, Levine RJ, et al. Angiogenic factors and the risk of adverse outcomes in women with suspected preeclampsia. Circulation. 2012;125(7):911–919.
Smies M, Damhuis SE, Duijnhoven RG, Leemhuis AG, Gordijn SJ, Ganzevoort W. Study protocol for a randomized trial on timely delivery versus expectant management in late preterm small for gestational age pregnancies with an abnormal umbilicocerebral ratio (UCR): the DRIGITAT study. Trials. 2022;23(1):619.
Arduini D, Rizzo G. Normal values of Pulsatility Index from fetal vessels: a cross‐sectional study on 1556 healthy fetuses. J Perinat Med. 1990;18(3):165–172.
Hadlock FP, Harris RB, Sharman RS, Deter RL, Park SK. Estimation of fetal weight with the use of head, body, and femur measurements—a prospective study. Am J Obstet Gynecol. 1985;151:333–337.
Hadlock FP, Harrist RB, Martinez‐Poyer J. In utero analysis of fetal growth: a sonographic weight standard. Radiology. 1991;181(1):129–133.
Verburg BO, Steegers EAP, De Ridder M, Snijders RJM, Smith E, Hofman A, et al. New charts for ultrasound dating of pregnancy andassessment of fetal growth: longitudinal data from a population‐based cohort study. Ultrasound Obstet Gynecol. 2008;31:388–396.
Wolf H, Stampalija T, Lees CC, TRUFFLE Study Group. Fetal cerebral blood‐flow redistribution: analysis of Doppler reference charts and association of different thresholds with adverse perinatal outcome. Ultrasound Obstet Gynecol. 2021;58(5):705–715.
Ayres‐de‐Campos D, Spong CY, Chandraharan E, Panel FIFMEC. FIGO consensus guidelines on intrapartum fetal monitoring: cardiotocography. Int J Gynaecol Obstet. 2015;131(1):13–24.
Patel D, Yulia A. Placental growth factor testing for pre‐eclampsia. Case Rep Womens Health. 2022;33:e00387.
Zeisler H, Llurba E, Chantraine F, Vatish M, Staff AC, Sennstrom M, et al. Predictive value of the sFlt‐1:PlGF ratio in women with suspected preeclampsia. N Engl J Med. 2016;374(1):13–22.
Verlohren S, Herraiz I, Lapaire O, Schlembach D, Zeisler H, Calda P, et al. New gestational phase‐specific cutoff values for the use of the soluble fms‐like tyrosine kinase‐1/placental growth factor ratio as a diagnostic test for preeclampsia. Hypertension. 2014;63(2):346–352.
Castor EDC. Castor Electronic Data Capture. 2019 [cited 2019 Aug 27]. Available from: https://castoredc.com.
Bayley N. Bayley Scales of infant and toddler development. 3rd ed. San Antonio, TX: Pearson; 2006.
Healy P, Gordijn S, Ganzevoort W, Beune I, Baschat A, Khalil A, et al. Core Outcome Set for GROwth restriction: deVeloping Endpoints (COSGROVE). Trials. 2018;19(1):451.
Brown MA, Magee LA, Kenny LC, Karumanchi SA, McCarthy FP, Saito S, et al. Hypertensive disorders of pregnancy: ISSHP classification, diagnosis, and management recommendations for international practice. Hypertension. 2018;72(1):24–43.
Kumar S, Figueras F, Ganzevoort W, Turner J, McCowan L. Using cerebroplacental ratio in non‐SGA fetuses to predict adverse perinatal outcome: caution is required. Ultrasound Obstet Gynecol. 2018;52(4):427–429.
Stampalija T, Wolf H, Mylrea‐Foley B, Marlow N, Stephens KJ, Shaw CJ, et al. Reduced fetal growth velocity and weight loss are associated with adverse perinatal outcome in fetuses at risk of growth restriction. Am J Obstet Gynecol. 2023;228(1):71.e1–71.e10.
Sovio U, White IR, Dacey A, Pasupathy D, Smith GCS. Screening for fetal growth restriction with universal third trimester ultrasonography in nulliparous women in the Pregnancy Outcome Prediction (POP) study: a prospective cohort study. Lancet. 2015;386(10008):2089–2097.
Mylrea‐Foley B, Wolf H, Stampalija T, Lees C, Truffle G, Authors T, et al. Longitudinal Doppler assessments in late preterm fetal growth restriction. Ultraschall Med. 2023;44(1):56–67.
Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, et al. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ. 2010;341:c7087.
Damhuis SE, Ganzevoort W, Gordijn SJ. Abnormal fetal growth: small for gestational age, fetal growth restriction, large for gestational age: definitions and epidemiology. Obstet Gynecol Clin North Am. 2021;48(2):267–279.
Braunholtz DA, Edwards SJ, Lilford RJ. Are randomized clinical trials good for us (in the short term)? Evidence for a “trial effect”. J Clin Epidemiol. 2001;54(3):217–224.
Landsberger HA. Hawthorne revisited: a plea for an open city. Ithaca, NY: Cornell University; 1957.
Mylrea‐Foley B, Thornton JG, Mullins E, Marlow N, Hecher K, Ammari C, et al. Perinatal and 2‐year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol. BMJ Open. 2022;12(4):e055543.
Figueras F, Gratacos E, Rial M, Gull I, Krofta L, Lubusky M, et al. Revealed versus concealed criteria for placental insufficiency in an unselected obstetric population in late pregnancy (RATIO37): randomised controlled trial study protocol. BMJ Open. 2017;7(6):e014835.
Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11:32.
معلومات مُعتمدة: Roche Diagnostics; 843002825 Netherlands ZONMW_ ZonMw
فهرسة مساهمة: Investigator: JM Schaaf; MA de Boer; JJ Zwart; AJM Huisjes; JHW Veerbeek; JOEH van Laar; S Al-Nasiry; HA Bremer; BBJ Hermsen; HP van de Nieuwenhof; M Sueters; DP van der Ham; MS Post; JA Kroese; JB Derks; JM Sikkema; JW de Leeuw
Keywords: Doppler velocimetry; cerebroplacental ratio; fetal growth restriction; placental insufficiency; small for gestational age; umbilicocerebral ratio
تواريخ الأحداث: Date Created: 20240318 Date Completed: 20240603 Latest Revision: 20240603
رمز التحديث: 20240603
DOI: 10.1111/1471-0528.17770
PMID: 38498267
قاعدة البيانات: MEDLINE
الوصف
تدمد:1471-0528
DOI:10.1111/1471-0528.17770