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

  • Clinicaltrials.gov identifier

    NCT03941886

  • Recruitment Status

    Recruiting

  • First Posted

    May 8, 2019

  • Last update posted

    January 27, 2021

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:Pre-Eclampsia
  • Intervention/Treatment: Other: Low-dose aspirin in women with high risk of preeclampsia
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: June 2023

Arms and interventions

Arm Intervention/treatment
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. 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.
  • 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

  • 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

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

Locations

China
Kunming Angel Women & Children Hospital
Kunming

China
Nanjing Drum Tower Hospital
Nanjing

Hong Kong
Kwong Wah Hospital
Hong Kong

Indonesia
Harapan Kita Hospital
Jakarta

Japan
Clinical Research Institute of Fetal Medicine
Osaka

Japan
Showa University Hospital
Tokyo

Japan
Japan Society for the Study of Hypertension in Pregnancy
Toyama

Malaysia
Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre
Bandar Tun Razak

Philippines
Philippine General Hospital
Manila

Singapore
National University Hospital
Singapore

Taiwan
Chang Gung Hospital
Taipei

Taiwan
Taiji Clinic
Taipei

Thailand
Chulalongkorn University Hospital
Bangkok

Thailand
Siriraj Hospital
Bangkok

Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai

Thailand
Thammasat University Hospital
Khlong Luang

Vietnam
Hanoi Obstetrics & Gynecology Hospital
Hanoi

Sponsors and Collaborators

Chiu Yee Liona Poon

Investigators

Principal Investigator: Liona CY Poon, MD Chinese University of Hong Kong

More Information