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This implementation study aims to evaluate the efficacy, acceptability, and safety of first-trimester screening and prevention for preterm-preeclampsia. It is a multicenter stepped wedge cluster randomized trial including maternity / diagnostic units from ten regions in Asia. The study involves a period where no intervention will take place at all recruiting units, and then at regular intervals, one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the Bayes based method followed by the commencement of low-dose aspirin in high-risk women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-intervention group | No Intervention | Participants receive routine prenatal care | |
| Intervention group | Experimental | Participants receive first-trimester screening for preterm-preeclampsia by the Bayes based method followed by commencement of low-dose aspirin prophylaxis in high-risk women. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose aspirin in women with high risk of preeclampsia | Other | Low-dose aspirin 150-162 mg/night or 100 mg/night if body weight <40 Kg, from <15 weeks till 36 weeks or, in the event of early delivery, at the onset of labor |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery with preterm-preeclampsia | Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups | Before 37 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation | including preeclampsia, gestational hypertension, small for gestational age birth weight (<5th percentile), stillbirth, placental abruption | at <34, <37 and ≥37 weeks of gestation |
| Neonatal mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liona CY Poon, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Women and Children's Medical Center | Guangzhou | China | ||||
| Kunming Angel Women & Children Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2962500 | Background | Geographic variation in the incidence of hypertension in pregnancy. World Health Organization International Collaborative Study of Hypertensive Disorders of Pregnancy. Am J Obstet Gynecol. 1988 Jan;158(1):80-3. | |
| 20598363 | Background | Steegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2. |
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This is a stepped wedge cluster-randomized trial. There are total of 7 clusters across Asia. This study involves a period where no intervention will take place at all recruiting units, i.e. routine prenatal care, and then at regular intervals (every 6 weekly), one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the Bayes based method followed by commencement of low-dose aspirin prophylaxis for high-risk women.
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A neonatal death is a death during 0-27 days of life. Composite neonatal morbidity (any one of the following): > grade II intraventricular hemorrhage; neonatal sepsis confirmed by cultures; neonatal anemia requiring transfusion; respiratory distress syndrome requiring surfactant and ventilation; necrotising enterocolitis requiring surgical intervention. Composite neonatal therapy (any one of the following): Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation. |
| during the first 28 days of life (0-27 days) |
| Low birth weight | Low birth weight <3rd, 5th and 10th percentile | at birth |
| Stillbirth | Fetal death at or after 20 to 28 weeks of pregnancy | at or after 20 to 28 weeks of pregnancy |
| Spontaneous preterm birth | Spontaneous preterm birth (SPB) includes preterm labor, preterm spontaneous rupture of membranes, preterm premature rupture of membranes (PPROM) and cervical weakness; it does not include indicated preterm delivery for maternal or fetal conditions. | At <34 and <37 weeks' gestation |
| Acceptability for PE screening | If subjects are under the intervention group upon proper consent procedure is done, at 11-13 weeks of gestation, the procedures below will be done.
The individual study participant's risk of preterm-PE will be computed using the Bayes based method. | in the first trimester of pregnancy (11-13 weeks of gestation) |
| Acceptability for aspirin treatment. | When patients are subjected to be high risks in preeclampsia screening, they will be asked if they accept the aspirin for treatment. If they do not accept, they will continue with routine care. The willingness of subjects will all be recorded on the Case report forms for data collection. | from <15 weeks till 36 weeks of gestation or, in the event of early delivery, at the onset of labor |
| Composite neonatal morbidity | Composite neonatal morbidity (any one of the following): > grade II intraventricular hemorrhage; neonatal sepsis confirmed by cultures; neonatal anemia requiring transfusion; respiratory distress syndrome requiring surfactant and ventilation; necrotising enterocolitis requiring surgical intervention. | during the first 28 days of life (0-27 days) |
| Composite neonatal therapy | Composite neonatal therapy (any one of the following): Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation. | during the first 28 days of life (0-27 days) |
| Gestational age at delivery | Gestational age at delivery | at delivery |
| Kunming |
| China |
| Nanjing Drum Tower Hospital | Nanjing | China |
| Prince of Wales Hospital | Hong Kong | Hong Kong, China | Shatin | Hong Kong |
| Kwong Wah Hospital | Hong Kong | Hong Kong |
| Harapan Kita Hospital | Jakarta | Indonesia |
| Clinical Research Institute of Fetal Medicine | Osaka | Japan |
| Showa University Hospital | Tokyo | Japan |
| Japan Society for the Study of Hypertension in Pregnancy | Toyama | Japan |
| Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre | Bandar Tun Razak | Malaysia |
| Philippine General Hospital | Manila | Philippines |
| National University Hospital | Singapore | Singapore |
| Chang Gung Hospital | Taipei | Taiwan |
| Taiji Clinic | Taipei | Taiwan |
| Chulalongkorn University Hospital | Bangkok | Thailand |
| Siriraj Hospital | Bangkok | Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | Thailand |
| Thammasat University Hospital | Khlong Luang | Thailand |
| Hanoi Obstetrics & Gynecology Hospital | Hanoi | Vietnam |
| 16581405 | Background | Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9. |
| 24150027 | Background | Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available. |
| 26104417 | Background | Tranquilli AL, Dekker G, Magee L, Roberts J, Sibai BM, Steyn W, Zeeman GG, Brown MA. The classification, diagnosis and management of the hypertensive disorders of pregnancy: A revised statement from the ISSHP. Pregnancy Hypertens. 2014 Apr;4(2):97-104. doi: 10.1016/j.preghy.2014.02.001. Epub 2014 Feb 15. No abstract available. |
| 22220321 | Background | National Collaborating Centre for Women's and Children's Health (UK). Hypertension in Pregnancy: The Management of Hypertensive Disorders During Pregnancy. London: RCOG Press; 2010 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK62652/ |
| 26287789 | Background | Committee Opinion No. 638: First-Trimester Risk Assessment for Early-Onset Preeclampsia. Obstet Gynecol. 2015 Sep;126(3):e25-e27. doi: 10.1097/AOG.0000000000001049. |
| 25724400 | Background | Wright D, Syngelaki A, Akolekar R, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal characteristics and medical history. Am J Obstet Gynecol. 2015 Jul;213(1):62.e1-62.e10. doi: 10.1016/j.ajog.2015.02.018. Epub 2015 Feb 25. |
| 26297382 | Background | O'Gorman N, Wright D, Syngelaki A, Akolekar R, Wright A, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 11-13 weeks gestation. Am J Obstet Gynecol. 2016 Jan;214(1):103.e1-103.e12. doi: 10.1016/j.ajog.2015.08.034. Epub 2015 Aug 19. |
| 28295782 | Background | O'Gorman N, Wright D, Poon LC, Rolnik DL, Syngelaki A, de Alvarado M, Carbone IF, Dutemeyer V, Fiolna M, Frick A, Karagiotis N, Mastrodima S, de Paco Matallana C, Papaioannou G, Pazos A, Plasencia W, Nicolaides KH. Multicenter screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation: comparison with NICE guidelines and ACOG recommendations. Ultrasound Obstet Gynecol. 2017 Jun;49(6):756-760. doi: 10.1002/uog.17455. |
| 28657417 | Background | Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28. |
| 18634131 | Background | Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402. |
| 22248988 | Background | Poon LC, Zymeri NA, Zamprakou A, Syngelaki A, Nicolaides KH. Protocol for measurement of mean arterial pressure at 11-13 weeks' gestation. Fetal Diagn Ther. 2012;31(1):42-8. doi: 10.1159/000335366. Epub 2012 Jan 13. |
| 40529816 | Derived | Chen Y, Nguyen-Hoang L, Dinh LT, Nguyen DA, Pooh RK, Shiozaki A, Zheng M, Hu Y, Ma R, Kusuma A, Wataganara T, Choolani MA, Kaneko M, Luewan S, Chang TY, Chaiyasit N, Nanthakomon T, Jiang Y, Shaw SW, Leung WC, Mohamad AS, Aguilar A, Lau SL, Lee NMW, Liu J, Sahota DS, Chong MKC, Papastefanou I, Poon LC. Effect of aspirin on small for gestational age neonates in pregnancies at high-risk for preeclampsia: a secondary analysis of a cluster randomised clinical trial. Lancet Reg Health West Pac. 2025 Jun 5;59:101582. doi: 10.1016/j.lanwpc.2025.101582. eCollection 2025 Jun. |
| 38923439 | Derived | Nguyen-Hoang L, Dinh LT, Tai AST, Nguyen DA, Pooh RK, Shiozaki A, Zheng M, Hu Y, Li B, Kusuma A, Yapan P, Gosavi A, Kaneko M, Luewan S, Chang TY, Chaiyasit N, Nanthakomon T, Liu H, Shaw SW, Leung WC, Mahdy ZA, Aguilar A, Leung HHY, Lee NMW, Lau SL, Wah IYM, Lu X, Sahota DS, Chong MKC, Poon LC; FORECAST Collaborators. Implementation of First-Trimester Screening and Prevention of Preeclampsia: A Stepped Wedge Cluster-Randomized Trial in Asia. Circulation. 2024 Oct 15;150(16):1223-1235. doi: 10.1161/CIRCULATIONAHA.124.069907. Epub 2024 Jun 26. |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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