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出境医 / 临床实验 / Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST) (FORECAST)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Other: Low-dose aspirin in women with high risk of preeclampsia Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52920 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023
Arms and Interventions
Arm Intervention/treatment
No Intervention: Non-intervention group
Participants receive routine prenatal care
Experimental: Intervention group
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
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
Outcome Measures
Primary Outcome Measures :
  1. Delivery with preterm-preeclampsia [ Time Frame: Before 37 weeks of gestation ]
    Proportions of delivery with preterm-preeclampsia between non-intervention and intervention groups


Secondary Outcome Measures :
  1. Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation [ Time Frame: at <34, <37 and ≥37 weeks of gestation ]
    including preeclampsia, gestational hypertension, small for gestational age birth weight (<5th percentile), stillbirth, placental abruption

  2. Neonatal mortality [ Time Frame: during the first 28 days of life (0-27 days) ]

    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.


  3. Low birth weight [ Time Frame: at birth ]
    Low birth weight <3rd, 5th and 10th percentile

  4. Stillbirth [ Time Frame: at or after 20 to 28 weeks of pregnancy ]
    Fetal death at or after 20 to 28 weeks of pregnancy

  5. Spontaneous preterm birth [ Time Frame: At <34 and <37 weeks' gestation ]
  6. The willingness of subjects accept to receive preeclampsia screening under the Bayes based method [ Time Frame: in the first trimester of pregnancy (11-13 weeks of gestation) ]

    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.

    1. Collection of maternal information (obstetrical, medical and drug history including aspirin intake with indication)
    2. Measurement of maternal MAP and UtA-PI will be measured according to standardized protocols.
    3. Blood sample will be drawn to determine of serum level of PIGF.

    The individual study participant's risk of preterm-PE will be computed using the Bayes based method.


  7. The willingness of high-risk subjects to accept aspirin treatment [ Time Frame: from <15 weeks till 36 weeks of gestation or, in the event of early delivery, at the onset of labor ]
    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.

  8. Composite neonatal morbidity [ Time Frame: during the first 28 days of life (0-27 days) ]
    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.

  9. Composite neonatal therapy [ Time Frame: during the first 28 days of life (0-27 days) ]
    Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Contacts
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Contact: Liona CY Prof Poon, MD (852) 3505 2582 liona.poon@cuhk.edu.hk

Locations
Show Show 17 study locations
Sponsors and Collaborators
Chiu Yee Liona Poon
Investigators
Layout table for investigator information
Principal Investigator: Liona CY Poon, MD Chinese University of Hong Kong
Tracking Information
First Submitted Date  ICMJE December 19, 2018
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE July 31, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019) 		Delivery with preterm-preeclampsia [ Time Frame: Before 37 weeks of gestation ]
Proportions of delivery with preterm-preeclampsia between non-intervention and intervention groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation [ Time Frame: at <34, <37 and ≥37 weeks of gestation ]
    including preeclampsia, gestational hypertension, small for gestational age birth weight (<5th percentile), stillbirth, placental abruption
  • Neonatal mortality [ Time Frame: during the first 28 days of life (0-27 days) ]
    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.
  • Low birth weight [ Time Frame: at birth ]
    Low birth weight <3rd, 5th and 10th percentile
  • Stillbirth [ Time Frame: at or after 20 to 28 weeks of pregnancy ]
    Fetal death at or after 20 to 28 weeks of pregnancy
  • Spontaneous preterm birth [ Time Frame: At <34 and <37 weeks' gestation ]
  • The willingness of subjects accept to receive preeclampsia screening under the Bayes based method [ Time Frame: in the first trimester of pregnancy (11-13 weeks of gestation) ]
    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.
    1. Collection of maternal information (obstetrical, medical and drug history including aspirin intake with indication)
    2. Measurement of maternal MAP and UtA-PI will be measured according to standardized protocols.
    3. Blood sample will be drawn to determine of serum level of PIGF.
    The individual study participant's risk of preterm-PE will be computed using the Bayes based method.
  • The willingness of high-risk subjects to accept aspirin treatment [ Time Frame: from <15 weeks till 36 weeks of gestation or, in the event of early delivery, at the onset of labor ]
    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.
  • Composite neonatal morbidity [ Time Frame: during the first 28 days of life (0-27 days) ]
    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 [ Time Frame: during the first 28 days of life (0-27 days) ]
    Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation [ Time Frame: at <34, <37 and ≥37 weeks of gestation ]
    including preeclampsia, gestational hypertension, small for gestational age birth weight (<5th percentile), stillbirth, placental abruption
  • Neonatal mortality [ Time Frame: during the first 28 days of life (0-27 days) ]
    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.
  • Low birth weight [ Time Frame: at birth ]
    Low birth weight <3rd, 5th and 10th percentile
  • Stillbirth [ Time Frame: at or after 20 to 28 weeks of pregnancy ]
    Fetal death at or after 20 to 28 weeks of pregnancy
  • Spontaneous preterm birth [ Time Frame: At <34 and <37 weeks' gestation ]
  • The willingness of subjects accept to receive preeclampsia screening under the Bayes based method [ Time Frame: in the first trimester of pregnancy ]
    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.
    1. Collection of maternal information (obstetrical, medical and drug history including aspirin intake with indication)
    2. Measurement of maternal MAP and UtA-PI will be measured according to standardized protocols.
    3. Blood sample will be drawn to determine of serum level of PIGF.
    The individual study participant's risk of preterm-PE will be computed using the Bayes based method.
  • The willingness of high-risk subjects to accept aspirin treatment [ Time Frame: from <15 weeks till 36 weeks of gestation or, in the event of early delivery, at the onset of labor ]
    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.
  • Composite neonatal morbidity [ Time Frame: during the first 28 days of life (0-27 days) ]
    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 [ Time Frame: during the first 28 days of life (0-27 days) ]
    Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)
Official Title  ICMJE Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pre-Eclampsia
Intervention  ICMJE Other: Low-dose aspirin in women with high risk of preeclampsia
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
Study Arms  ICMJE
  • No Intervention: Non-intervention group
    Participants receive routine prenatal care
  • Experimental: Intervention group
    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.
    Intervention: Other: Low-dose aspirin in women with high risk of preeclampsia
Publications *
  • 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.
  • 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. Review.
  • Khan KS, Wojdyla D, Say L, Gülmezoglu 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. Review.
  • 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.
  • 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.
  • 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.
  • 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. Review.
  • 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.
  • 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.
  • 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. Erratum in: Ultrasound Obstet Gynecol. 2017 Dec;50(6):807.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019) 		52920
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liona CY Prof Poon, MD (852) 3505 2582 liona.poon@cuhk.edu.hk
Listed Location Countries  ICMJE China,   Hong Kong,   Indonesia,   Japan,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941886
Other Study ID Numbers  ICMJE 2018-0434
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chiu Yee Liona Poon, Chinese University of Hong Kong
Study Sponsor  ICMJE Chiu Yee Liona Poon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Liona CY Poon, MD Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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