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

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ClinicalTrials.gov Identifier: NCT03941886
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Chiu Yee Liona Poon, Chinese University of Hong Kong

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

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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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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




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.



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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941886


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

Locations
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China
Kunming Angel Women & Children Hospital Not yet recruiting
Kunming, China
Contact: Ruimei Ma, MD, PhD         
Nanjing Drum Tower Hospital Not yet recruiting
Nanjing, China
Contact: Yali Hu, MD         
Hong Kong
Kwong Wah Hospital Not yet recruiting
Hong Kong, Hong Kong
Contact: Wing Cheong Leung, MD         
Indonesia
Harapan Kita Hospital Not yet recruiting
Jakarta, Indonesia
Contact: Aditya Kusuma         
Japan
Clinical Research Institute of Fetal Medicine Not yet recruiting
Osaka, Japan
Contact: Ritsuko K Pooh         
Showa University Hospital Not yet recruiting
Tokyo, Japan
Contact: Akihiko Sekizawa         
Japan Society for the Study of Hypertension in Pregnancy Not yet recruiting
Toyama, Japan
Contact: Shigeru Saito         
Malaysia
Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre Not yet recruiting
Bandar Tun Razak, Malaysia
Contact: Zaleha Abdullah Mahdy         
Philippines
Philippine General Hospital Not yet recruiting
Manila, Philippines
Contact: Angela Aguilar         
Singapore
National University Hospital Active, not recruiting
Singapore, Singapore
Taiwan
Chang Gung Hospital Not yet recruiting
Taipei, Taiwan
Contact: Steven Shaw, MD         
Taiji Clinic Not yet recruiting
Taipei, Taiwan
Contact: Tung-Yao Chang, MD         
Thailand
Chulalongkorn University Hospital Not yet recruiting
Bangkok, Thailand
Contact: Noppadol Chaiyasit, MD         
Siriraj Hospital Not yet recruiting
Bangkok, Thailand
Contact: Tuangsit Wataganara, MD         
Maharaj Nakorn Chiang Mai Hospital Not yet recruiting
Chiang Mai, Thailand
Contact: Suchaya Luewan, MD, PhD         
Thammasat University Hospital Not yet recruiting
Khlong Luang, Thailand
Contact: Tongta Nanthakomon, MD         
Vietnam
Hanoi Obstetrics & Gynecology Hospital Not yet recruiting
Hanoi, Vietnam
Contact: Linh Dinh, MD         
Sponsors and Collaborators
Chiu Yee Liona Poon
Investigators
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Principal Investigator: Liona CY Poon, MD Chinese University of Hong Kong

Publications:

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Responsible Party: Chiu Yee Liona Poon, Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03941886     History of Changes
Other Study ID Numbers: 2018-0434
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Chiu Yee Liona Poon, Chinese University of Hong Kong:
Pre-Eclampsia
Aspirin
Additional relevant MeSH terms:
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Aspirin
Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics