General health and social outcomes 50 years after exposure to antenatal betamethasone: follow-up of a randomised controlled trial.

IF 7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Anthony G B Walters, Greg D Gamble, Caroline A Crowther, Stuart R Dalziel, Carl L Eagleton, Christopher J D McKinlay, Barry J Milne, Jane E Harding
{"title":"General health and social outcomes 50 years after exposure to antenatal betamethasone: follow-up of a randomised controlled trial.","authors":"Anthony G B Walters, Greg D Gamble, Caroline A Crowther, Stuart R Dalziel, Carl L Eagleton, Christopher J D McKinlay, Barry J Milne, Jane E Harding","doi":"10.1186/s12916-024-03732-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Antenatal corticosteroids are recommended for women at risk of preterm birth from 24 to 34 weeks' gestation as they reduce neonatal morbidity and mortality, but evidence regarding their long-term effects on offspring is limited. This study assessed general health and social outcomes 50 years after antenatal exposure to corticosteroids.</p><p><strong>Methods: </strong>We assessed 424 adult offspring of women who participated in the first randomised, double-blind, placebo-controlled trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome. The first 717 mothers received two intramuscular injections of betamethasone (6 mg betamethasone sodium phosphate and 6 mg betamethasone acetate) or placebo given 24 h apart and the subsequent 398 received two injections of double dose betamethasone (12 mg betamethasone sodium phosphate and 12 mg betamethasone acetate) or equivalent volume of placebo. Follow-up included a health questionnaire and consent for access to administrative data sources. Outcome categories included mental health (depression, anxiety, bipolar affective disorder, schizophrenia and treatment or hospital admission for any mental health disorder), general health (chronic kidney disease, cancer diagnosis, bone fracture, oral health, allergies, functional difficulties and physical activity) and social outcomes (educational attainment, employment and criminal convictions). Investigators remained blinded to treatment allocation. Analyses were adjusted for gestational age at entry, sex and clustering.</p><p><strong>Results: </strong>We assessed 424 adult offspring (46% of survivors; mean [SD] age 49.3 [1.0] years; 212 [50%] female). There was no difference in mental health, general health and social outcomes between those exposed to betamethasone and those exposed to placebo, with the exception that osteoporotic site fracture in adulthood was more likely to have occurred in the betamethasone group compared with placebo (adjusted relative risk 1.57, 95% CI 1.00, 2.48, p = 0.05). No dose-effect relationship was evident and there was no difference in the proportion with at least one fracture. Follow-up rate and lack of in-person assessments were the main limitations.</p><p><strong>Conclusions: </strong>There is no evidence that antenatal corticosteroids have clinically important effects on general health and social outcomes up to 50 years of age.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":null,"pages":null},"PeriodicalIF":7.0000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11533403/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12916-024-03732-1","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Antenatal corticosteroids are recommended for women at risk of preterm birth from 24 to 34 weeks' gestation as they reduce neonatal morbidity and mortality, but evidence regarding their long-term effects on offspring is limited. This study assessed general health and social outcomes 50 years after antenatal exposure to corticosteroids.

Methods: We assessed 424 adult offspring of women who participated in the first randomised, double-blind, placebo-controlled trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome. The first 717 mothers received two intramuscular injections of betamethasone (6 mg betamethasone sodium phosphate and 6 mg betamethasone acetate) or placebo given 24 h apart and the subsequent 398 received two injections of double dose betamethasone (12 mg betamethasone sodium phosphate and 12 mg betamethasone acetate) or equivalent volume of placebo. Follow-up included a health questionnaire and consent for access to administrative data sources. Outcome categories included mental health (depression, anxiety, bipolar affective disorder, schizophrenia and treatment or hospital admission for any mental health disorder), general health (chronic kidney disease, cancer diagnosis, bone fracture, oral health, allergies, functional difficulties and physical activity) and social outcomes (educational attainment, employment and criminal convictions). Investigators remained blinded to treatment allocation. Analyses were adjusted for gestational age at entry, sex and clustering.

Results: We assessed 424 adult offspring (46% of survivors; mean [SD] age 49.3 [1.0] years; 212 [50%] female). There was no difference in mental health, general health and social outcomes between those exposed to betamethasone and those exposed to placebo, with the exception that osteoporotic site fracture in adulthood was more likely to have occurred in the betamethasone group compared with placebo (adjusted relative risk 1.57, 95% CI 1.00, 2.48, p = 0.05). No dose-effect relationship was evident and there was no difference in the proportion with at least one fracture. Follow-up rate and lack of in-person assessments were the main limitations.

Conclusions: There is no evidence that antenatal corticosteroids have clinically important effects on general health and social outcomes up to 50 years of age.

产前使用倍他米松 50 年后的总体健康和社会影响:随机对照试验的后续研究。
背景:产前皮质类固醇可降低新生儿的发病率和死亡率,因此被推荐用于妊娠 24 至 34 周有早产风险的妇女,但有关其对后代的长期影响的证据却很有限。本研究对产前接触皮质类固醇 50 年后的一般健康和社会结果进行了评估:我们对 424 名参加了首例产前倍他米松预防新生儿呼吸窘迫综合征随机、双盲、安慰剂对照试验的妇女的成年后代进行了评估。首批 717 名母亲接受了两次倍他米松(6 毫克倍他米松磷酸钠和 6 毫克倍他米松醋酸盐)或安慰剂肌肉注射,每次间隔 24 小时;随后的 398 名母亲接受了两次双剂量倍他米松(12 毫克倍他米松磷酸钠和 12 毫克倍他米松醋酸盐)或等量安慰剂注射。随访包括健康问卷调查和同意访问管理数据源。结果类别包括心理健康(抑郁、焦虑、双相情感障碍、精神分裂症以及因任何心理健康障碍而接受治疗或入院)、一般健康(慢性肾病、癌症诊断、骨折、口腔健康、过敏、功能障碍和体育活动)和社会结果(教育程度、就业和刑事定罪)。研究人员对治疗分配保持盲法。分析结果根据入选时的妊娠年龄、性别和聚类进行了调整:我们对 424 名成年后代(幸存者的 46%;平均 [SD] 年龄 49.3 [1.0] 岁;212 [50%] 名女性)进行了评估。接受倍他米松治疗的患者与接受安慰剂治疗的患者在心理健康、一般健康和社会结果方面没有差异,但倍他米松组与安慰剂组相比,成年后发生骨质疏松性部位骨折的可能性更大(调整后相对风险为1.57,95% CI为1.00,2.48,p = 0.05)。剂量效应关系并不明显,至少发生一次骨折的比例也没有差异。随访率和缺乏亲自评估是主要的局限性:没有证据表明产前皮质类固醇对50岁前的一般健康和社会结果有重要的临床影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
BMC Medicine
BMC Medicine 医学-医学:内科
CiteScore
13.10
自引率
1.10%
发文量
435
审稿时长
4-8 weeks
期刊介绍: BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信