Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)

NCT03941886 | Completed DMC

• 1 other identifier: 2018-0434
• Study Type: interventional
• Target: 42,454
• Locations: 10 countries
• Sites: 19

Brief Summary

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.

Conditions

Pre-Eclampsia

Keywords

Pre-Eclampsia; Aspirin

Outcome Measures

Primary Outcomes (1)

• Delivery with preterm-preeclampsia

  Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups

  Before 37 weeks of gestation

Secondary Outcomes (10)

• Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation

  at <34, <37 and ≥37 weeks of gestation

• Neonatal mortality

  during the first 28 days of life (0-27 days)

• Low birth weight

  at birth

• Stillbirth

  at or after 20 to 28 weeks of pregnancy

• Spontaneous preterm birth

  At <34 and <37 weeks' gestation

Study Arms (2)

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.

Other: Low-dose aspirin in women with high risk of preeclampsia

Interventions

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy;
• Live fetus;

You may not qualify if:

• Multiple pregnancy;
• Major fetal defects identified at 11-13 weeks of assessment;
• Non-viable fetus (missed spontaneous abortion or stillbirth).

Sponsors & Collaborators

• Chiu Yee Liona Poon: lead

Study Sites (19)

Guangzhou Women and Children's Medical Center

Guangzhou, China

Location

Kunming Angel Women & Children Hospital

Kunming, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

Prince of Wales Hospital

Hong Kong, Hong Kong, China, Shatin, Hong Kong

Location

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

Harapan Kita Hospital

Jakarta, Indonesia

Location

Clinical Research Institute of Fetal Medicine

Osaka, Japan

Location

Showa University Hospital

Tokyo, Japan

Location

Japan Society for the Study of Hypertension in Pregnancy

Toyama, Japan

Location

Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre

Bandar Tun Razak, Malaysia

Location

Philippine General Hospital

Manila, Philippines

Location

National University Hospital

Singapore, Singapore

Location

Chang Gung Hospital

Taipei, Taiwan

Location

Taiji Clinic

Taipei, Taiwan

Location

Chulalongkorn University Hospital

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Location

Thammasat University Hospital

Khlong Luang, Thailand

Location

Hanoi Obstetrics & Gynecology Hospital

Hanoi, Vietnam

Location

Related Publications (15)

• 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.

  PMID: 2962500 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.

  PMID: 20598363 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.

  PMID: 16581405 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.

  PMID: 24150027 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.

  PMID: 26104417 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/

  PMID: 22220321 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.

  PMID: 26287789 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.

  PMID: 25724400 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.

  PMID: 26297382 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.

  PMID: 28295782 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.

  PMID: 28657417 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.

  PMID: 18634131 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.

  PMID: 22248988 BACKGROUND

• 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.

  PMID: 40529816 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.

  PMID: 38923439 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Liona CY Poon, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor (Clinical)

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: May 8, 2019
• Study Start: July 31, 2019
• Primary Completion: June 15, 2023
• Study Completion: August 15, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2); MY (1); TH (4); SG (1); PH (1); CN (3); VN (1); ID (1); JP (3); TW (2)