Clinical trial NCT03941886: Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)
Official title: Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Keywords: Pre-Eclampsia
Aspirin
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 42454
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy;
* Live fetus;

Exclusion Criteria:

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

Primary outcomes:
measure: Delivery with preterm-preeclampsia
timeFrame: Before 37 weeks of gestation
Secondary outcomes:
measure: Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation
timeFrame: at <34, <37 and ≥37 weeks of gestation
measure: Neonatal mortality
timeFrame: during the first 28 days of life (0-27 days)
measure: Low birth weight
timeFrame: at birth
measure: Stillbirth
timeFrame: at or after 20 to 28 weeks of pregnancy
measure: Spontaneous preterm birth
timeFrame: At <34 and <37 weeks' gestation
measure: Acceptability for PE screening
timeFrame: in the first trimester of pregnancy (11-13 weeks of gestation)
measure: Acceptability for aspirin treatment.
timeFrame: from <15 weeks till 36 weeks of gestation or, in the event of early delivery, at the onset of labor
measure: Composite neonatal morbidity
timeFrame: during the first 28 days of life (0-27 days)
measure: Composite neonatal therapy
timeFrame: during the first 28 days of life (0-27 days)
measure: Gestational age at delivery
timeFrame: at delivery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
city: Kunming
country: China
facility: Kunming Angel Women & Children Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Hong Kong, China
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Jakarta
country: Indonesia
facility: Harapan Kita Hospital
city: Osaka
country: Japan
facility: Clinical Research Institute of Fetal Medicine
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Toyama
country: Japan
facility: Japan Society for the Study of Hypertension in Pregnancy
city: Bandar Tun Razak
country: Malaysia
facility: Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Taipei
country: Taiwan
facility: Chang Gung Hospital
city: Taipei
country: Taiwan
facility: Taiji Clinic
city: Bangkok
country: Thailand
facility: Chulalongkorn University Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Khlong Luang
country: Thailand
facility: Thammasat University Hospital
city: Hanoi
country: Vietnam
facility: Hanoi Obstetrics & Gynecology Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Liona CY Poon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.