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

Last updated: November 26, 2023
Sponsor: Chiu Yee Liona Poon
Overall Status: Completed

Phase

N/A

Condition

Pregnancy Complications

Treatment

Low-dose aspirin in women with high risk of preeclampsia

Clinical Study ID

NCT03941886
2018-0434
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

  • Singleton pregnancy;
  • Live fetus;

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 42454
Treatment Group(s): 1
Primary Treatment: Low-dose aspirin in women with high risk of preeclampsia
Phase:
Study Start date:
July 31, 2019
Estimated Completion Date:
August 15, 2023

Connect with a study center

  • Guangzhou Women and Children's Medical Center

    Guangzhou,
    China

    Site Not Available

  • Kunming Angel Women & Children Hospital

    Kunming,
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing,
    China

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong, Hong Kong, China Shatin
    Hong Kong

    Site Not Available

  • Kwong Wah Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Harapan Kita Hospital

    Jakarta,
    Indonesia

    Site Not Available

  • Clinical Research Institute of Fetal Medicine

    Osaka,
    Japan

    Site Not Available

  • Showa University Hospital

    Tokyo,
    Japan

    Site Not Available

  • Japan Society for the Study of Hypertension in Pregnancy

    Toyama,
    Japan

    Site Not Available

  • Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre

    Bandar Tun Razak,
    Malaysia

    Site Not Available

  • Philippine General Hospital

    Manila,
    Philippines

    Site Not Available

  • National University Hospital

    Singapore,
    Singapore

    Site Not Available

  • Chang Gung Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Taiji Clinic

    Taipei,
    Taiwan

    Site Not Available

  • Chulalongkorn University Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Siriraj Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai,
    Thailand

    Site Not Available

  • Thammasat University Hospital

    Khlong Luang,
    Thailand

    Site Not Available

  • Hanoi Obstetrics & Gynecology Hospital

    Hanoi,
    Vietnam

    Site Not Available

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