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

Primary Purpose

Pre-Eclampsia

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Low-dose aspirin in women with high risk of preeclampsia
Sponsored by
Chiu Yee Liona Poon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-Eclampsia focused on measuring Pre-Eclampsia, Aspirin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Guangzhou Women and Children's Medical CenterRecruiting
  • Kunming Angel Women & Children HospitalRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • Prince of Wales HospitalRecruiting
  • Kwong Wah HospitalRecruiting
  • Harapan Kita HospitalRecruiting
  • Clinical Research Institute of Fetal MedicineRecruiting
  • Showa University HospitalRecruiting
  • Japan Society for the Study of Hypertension in PregnancyRecruiting
  • Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical CentreRecruiting
  • Philippine General HospitalRecruiting
  • National University HospitalRecruiting
  • Chang Gung HospitalRecruiting
  • Taiji ClinicRecruiting
  • Chulalongkorn University HospitalRecruiting
  • Siriraj HospitalRecruiting
  • Maharaj Nakorn Chiang Mai HospitalRecruiting
  • Thammasat University HospitalRecruiting
  • Hanoi Obstetrics & Gynecology HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Non-intervention group

Intervention group

Arm Description

Participants receive routine prenatal care

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Neonatal mortality
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
Low birth weight <3rd, 5th and 10th percentile
Stillbirth
Fetal death at or after 20 to 28 weeks of pregnancy
Spontaneous preterm birth
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. Collection of maternal information (obstetrical, medical and drug history including aspirin intake with indication) Measurement of maternal MAP and UtA-PI will be measured according to standardized protocols. 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.
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.
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.
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.
Gestational age at delivery

Full Information

First Posted
December 19, 2018
Last Updated
May 24, 2023
Sponsor
Chiu Yee Liona Poon
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1. Study Identification

Unique Protocol Identification Number
NCT03941886
Brief Title
Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)
Acronym
FORECAST
Official Title
Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chiu Yee Liona Poon

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia
Keywords
Pre-Eclampsia, Aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
68250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-intervention group
Arm Type
No Intervention
Arm Description
Participants receive routine prenatal care
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Low-dose aspirin in women with high risk of preeclampsia
Intervention Description
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
Primary Outcome Measure Information:
Title
Delivery with preterm-preeclampsia
Description
Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups
Time Frame
Before 37 weeks of gestation
Secondary Outcome Measure Information:
Title
Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation
Description
including preeclampsia, gestational hypertension, small for gestational age birth weight (<5th percentile), stillbirth, placental abruption
Time Frame
at <34, <37 and ≥37 weeks of gestation
Title
Neonatal mortality
Description
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.
Time Frame
during the first 28 days of life (0-27 days)
Title
Low birth weight
Description
Low birth weight <3rd, 5th and 10th percentile
Time Frame
at birth
Title
Stillbirth
Description
Fetal death at or after 20 to 28 weeks of pregnancy
Time Frame
at or after 20 to 28 weeks of pregnancy
Title
Spontaneous preterm birth
Time Frame
At <34 and <37 weeks' gestation
Title
Acceptability for PE screening
Description
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. Collection of maternal information (obstetrical, medical and drug history including aspirin intake with indication) Measurement of maternal MAP and UtA-PI will be measured according to standardized protocols. 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.
Time Frame
in the first trimester of pregnancy (11-13 weeks of gestation)
Title
Acceptability for aspirin treatment.
Description
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.
Time Frame
from <15 weeks till 36 weeks of gestation or, in the event of early delivery, at the onset of labor
Title
Composite neonatal morbidity
Description
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.
Time Frame
during the first 28 days of life (0-27 days)
Title
Composite neonatal therapy
Description
Composite neonatal therapy (any one of the following): Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation.
Time Frame
during the first 28 days of life (0-27 days)
Title
Gestational age at delivery
Time Frame
at delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liona CY Prof Poon, MD
Phone
(852) 3505 2582
Email
liona.poon@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liona CY Poon, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huishu Liu
Facility Name
Kunming Angel Women & Children Hospital
City
Kunming
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruimei Ma, MD, PhD
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yali Hu, MD
Facility Name
Prince of Wales Hospital
City
Hong Kong
State/Province
Hong Kong, China
ZIP/Postal Code
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liona Poon, MD
Email
liona.poon@cuhk.edu.hk
Facility Name
Kwong Wah Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wing Cheong Leung, MD
Facility Name
Harapan Kita Hospital
City
Jakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aditya Kusuma
Facility Name
Clinical Research Institute of Fetal Medicine
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ritsuko K Pooh
Facility Name
Showa University Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akihiko Sekizawa
Facility Name
Japan Society for the Study of Hypertension in Pregnancy
City
Toyama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeru Saito
Facility Name
Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre
City
Bandar Tun Razak
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaleha Abdullah Mahdy
Facility Name
Philippine General Hospital
City
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Aguilar
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahesh A Choolani, MD, PhD
Facility Name
Chang Gung Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Shaw, MD
Facility Name
Taiji Clinic
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tung-Yao Chang, MD
Facility Name
Chulalongkorn University Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noppadol Chaiyasit, MD
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuangsit Wataganara, MD
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suchaya Luewan, MD, PhD
Facility Name
Thammasat University Hospital
City
Khlong Luang
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tongta Nanthakomon, MD
Facility Name
Hanoi Obstetrics & Gynecology Hospital
City
Hanoi
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linh Dinh, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2962500
Citation
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20598363
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.
Results Reference
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PubMed Identifier
16581405
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.
Results Reference
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PubMed Identifier
24150027
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.
Results Reference
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PubMed Identifier
26104417
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.
Results Reference
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PubMed Identifier
22220321
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/
Results Reference
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PubMed Identifier
26287789
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.
Results Reference
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PubMed Identifier
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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.
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Citation
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PubMed Identifier
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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. Erratum In: Ultrasound Obstet Gynecol. 2017 Dec;50(6):807.
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Citation
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Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)

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