Implementation of First-Trimester Screening and Prevention of Preeclampsia: A Stepped Wedge Cluster-Randomized Trial in Asia.

Autor:	Nguyen-Hoang L; Department of Obstetrics and Gynaecology, Prince of Wales Hospital (L.N.-H., A.S.T.T., H.H.Y.L., N.M.W.L., S.L.L., I.Y.M.W., X.L., D.S.S., L.C.P.), Chinese University of Hong Kong., Dinh LT; Center for Prenatal and Neonatal Screening and Diagnosis, Hanoi Obstetrics and Gynecology Hospital, Vietnam (L.T.D., D.-A.N.)., Tai AST; Department of Obstetrics and Gynaecology, Prince of Wales Hospital (L.N.-H., A.S.T.T., H.H.Y.L., N.M.W.L., S.L.L., I.Y.M.W., X.L., D.S.S., L.C.P.), Chinese University of Hong Kong., Nguyen DA; Center for Prenatal and Neonatal Screening and Diagnosis, Hanoi Obstetrics and Gynecology Hospital, Vietnam (L.T.D., D.-A.N.)., Pooh RK; Clinical Research Institute of Fetal Medicine Prenatal Medical Clinic, Osaka, Japan (R.K.P.)., Shiozaki A; Department of Obstetrics and Gynecology, Toyama University Hospital, Toyama, Japan (A.S.)., Zheng M; Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School, China (M.Z., Y.H.)., Hu Y; Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School, China (M.Z., Y.H.)., Li B; Department of Obstetrics and Gynecology, Kunming Angel Women and Children's Hospital, Teaching Hospital of Kunming University of Science and Technology, China (B.L.)., Kusuma A; Department of Obstetrics and Gynecology, Harapan Kita Women and Children Hospital, Jakarta, Indonesia (A.K.)., Yapan P; Department of Obstetrics and Gynecology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (P.Y.)., Gosavi A; Department of Obstetrics and Gynecology, Yong Loo Lin School of Medicine, National University of Singapore (A.G.)., Kaneko M; Department of Obstetrics and Gynecology, Showa University Hospital, Tokyo, Japan (M.K.)., Luewan S; Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Thailand (S.L.)., Chang TY; Department of Fetal Medicine, Taiji Clinic, Taipei, Taiwan (T.-Y.C.)., Chaiyasit N; Department of Obstetrics and Gynecology, King Chulalongkorn Memorial Hospital, Bangkok, Thailand (N.C.)., Nanthakomon T; Department of Obstetrics and Gynecology, Faculty of Medicine, Thammasat University, Pathumthani, Thailand (T.N.)., Liu H; Department of Obstetrics, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, China (H.L.)., Shaw SW; Department of Obstetrics and Gynecology, Taipei Chang Gung Memorial Hospital, Taiwan (S.W.S.)., Leung WC; Department of Obstetrics and Gynaecology, Kwong Wah Hospital, Hong Kong SAR, China (W.C.L.)., Mahdy ZA; Department of Obstetrics and Gynaecology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Cheras, Malaysia (Z.A.M.)., Aguilar A; Department of Obstetrics and Gynecology, University of the Philippines College of Medicine, Philippine General Hospital, Manila (A.A.)., Leung HHY; Department of Obstetrics and Gynaecology, Prince of Wales Hospital (L.N.-H., A.S.T.T., H.H.Y.L., N.M.W.L., S.L.L., I.Y.M.W., X.L., D.S.S., L.C.P.), Chinese University of Hong Kong., Lee NMW; Department of Obstetrics and Gynaecology, Prince of Wales Hospital (L.N.-H., A.S.T.T., H.H.Y.L., N.M.W.L., S.L.L., I.Y.M.W., X.L., D.S.S., L.C.P.), Chinese University of Hong Kong., Lau SL; Department of Obstetrics and Gynaecology, Prince of Wales Hospital (L.N.-H., A.S.T.T., H.H.Y.L., N.M.W.L., S.L.L., I.Y.M.W., X.L., D.S.S., L.C.P.), Chinese University of Hong Kong., Wah IYM; Department of Obstetrics and Gynaecology, Prince of Wales Hospital (L.N.-H., A.S.T.T., H.H.Y.L., N.M.W.L., S.L.L., I.Y.M.W., X.L., D.S.S., L.C.P.), Chinese University of Hong Kong., Lu X; Department of Obstetrics and Gynaecology, Prince of Wales Hospital (L.N.-H., A.S.T.T., H.H.Y.L., N.M.W.L., S.L.L., I.Y.M.W., X.L., D.S.S., L.C.P.), Chinese University of Hong Kong., Sahota DS; Department of Obstetrics and Gynaecology, Prince of Wales Hospital (L.N.-H., A.S.T.T., H.H.Y.L., N.M.W.L., S.L.L., I.Y.M.W., X.L., D.S.S., L.C.P.), Chinese University of Hong Kong., Chong MKC; Jockey Club School of Public Health and Primary Care, Faculty of Medicine (M.K.C.C.), Chinese University of Hong Kong., Poon LC; Department of Obstetrics and Gynaecology, Prince of Wales Hospital (L.N.-H., A.S.T.T., H.H.Y.L., N.M.W.L., S.L.L., I.Y.M.W., X.L., D.S.S., L.C.P.), Chinese University of Hong Kong.
Jazyk:	angličtina
Zdroj:	Circulation [Circulation] 2024 Oct 15; Vol. 150 (16), pp. 1223-1235. Date of Electronic Publication: 2024 Jun 26.
DOI:	10.1161/CIRCULATIONAHA.124.069907
Abstrakt:	Background: This trial aimed to assess the efficacy, acceptability, and safety of a first-trimester screen-and-prevent strategy for preterm preeclampsia in Asia. Methods: Between August 1, 2019, and February 28, 2022, this multicenter stepped wedge cluster randomized trial included maternity/diagnostic units from 10 regions in Asia. The trial started with a period where all recruiting centers provided routine antenatal care without study-related intervention. At regular 6-week intervals, one cluster was randomized to transit from nonintervention phase to intervention phase. In the intervention phase, women underwent first-trimester screening for preterm preeclampsia using a Bayes theorem-based triple-test. High-risk women, with adjusted risk for preterm preeclampsia ≥1 in 100, received low-dose aspirin from <16 weeks until 36 weeks. Results: Overall, 88.04% (42 897 of 48 725) of women agreed to undergo first-trimester screening for preterm preeclampsia. Among those identified as high-risk in the intervention phase, 82.39% (2919 of 3543) received aspirin prophylaxis. There was no significant difference in the incidence of preterm preeclampsia between the intervention and non-intervention phases (adjusted odds ratio [aOR], 1.59 [95% CI, 0.91-2.77]). However, among high-risk women in the intervention phase, aspirin prophylaxis was significantly associated with a 41% reduction in the incidence of preterm preeclampsia (aOR, 0.59 [95% CI, 0.37-0.92]). In addition, it correlated with 54%, 55%, and 64% reduction in the incidence of preeclampsia with delivery at <34 weeks (aOR, 0.46 [95% CI, 0.23-0.93]), spontaneous preterm birth <34 weeks (aOR, 0.45 [95% CI, 0.22-0.92]), and perinatal death (aOR, 0.34 [95% CI, 0.12-0.91]), respectively. There was no significant between-group difference in the incidence of aspirin-related severe adverse events. Conclusions: The implementation of the screen-and-prevent strategy for preterm preeclampsia is not associated with a significant reduction in the incidence of preterm preeclampsia. However, low-dose aspirin effectively reduces the incidence of preterm preeclampsia by 41% among high-risk women. The screen-and-prevent strategy for preterm preeclampsia is highly accepted by a diverse group of women from various ethnic backgrounds beyond the original population where the strategy was developed. These findings underpin the importance of the widespread implementation of the screen-and-prevent strategy for preterm preeclampsia on a global scale. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03941886. Competing Interests: L.C.P. has received speaker fees and consultancy payments from Roche Diagnostics and Ferring Pharmaceuticals. In addition, she has received in-kind contributions from Roche Diagnostics, Revvity Inc (formerly PerkinElmer Life and Analytical Sciences), Thermo Fisher Scientific, Ningbo Aucheer Biological Technology Co, Ltd, and GE HealthCare. D.S.S. has received in-kind contributions from Revvity Inc, Thermo Fisher Scientific, Roche Diagnostics, Diabetomics, and Ningbo Aucheer Biological Technology Co, Ltd. R.K.P. is chief executive officer of Ritz Medical Co Ltd, a genetic testing company, and holds shares in and receives executive compensation from it. The other authors report no conflicts.
Databáze:	MEDLINE
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