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

November 26, 2023 updated by: Chiu Yee Liona Poon

Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42454

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • Guangzhou Women And Children's Medical Center
      • Kunming, China
        • Kunming Angel Women & Children Hospital
      • Nanjing, China
        • Nanjing Drum Tower Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Kwong Wah Hospital
    • Hong Kong, China
      • Hong Kong, Hong Kong, China, Hong Kong, Shatin
        • Prince of Wales Hospital
  • Indonesia
      • Jakarta, Indonesia
        • Harapan Kita Hospital
  • Japan
      • Osaka, Japan
        • Clinical Research Institute of Fetal Medicine
      • Tokyo, Japan
        • Showa University Hospital
      • Toyama, Japan
        • Japan Society for the Study of Hypertension in Pregnancy
  • Malaysia
      • Bandar Tun Razak, Malaysia
        • Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre
  • Philippines
      • Manila, Philippines
        • Philippine General Hospital
  • Singapore
      • Singapore, Singapore
        • National University Hospital
  • Taiwan
      • Taipei, Taiwan
        • Chang Gung Hospital
      • Taipei, Taiwan
        • Taiji Clinic
  • Thailand
      • Bangkok, Thailand
        • Siriraj Hospital
      • Bangkok, Thailand
        • Chulalongkorn University Hospital
      • Chiang Mai, Thailand
        • Maharaj Nakorn Chiang Mai Hospital
      • Khlong Luang, Thailand
        • Thammasat University Hospital
  • Vietnam
      • Hanoi, Vietnam
        • Hanoi Obstetrics & Gynecology Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery with preterm-preeclampsia
Time Frame: Before 37 weeks of gestation
Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups
Before 37 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at <34, <37 and ≥37 weeks of gestation
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.
during the first 28 days of life (0-27 days)
Low birth weight
Time Frame: at birth
Low birth weight <3rd, 5th and 10th percentile
at birth
Stillbirth
Time Frame: at or after 20 to 28 weeks of pregnancy
Fetal death at or after 20 to 28 weeks of pregnancy
at or after 20 to 28 weeks of pregnancy
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.
during the first 28 days of life (0-27 days)
Acceptability for PE screening
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.
in the first trimester of pregnancy (11-13 weeks of gestation)
Acceptability for 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.
from <15 weeks till 36 weeks of gestation or, in the event of early delivery, at the onset of labor
Composite neonatal therapy
Time Frame: during the first 28 days of life (0-27 days)
Composite neonatal therapy (any one of the following): Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation.
during the first 28 days of life (0-27 days)
Spontaneous preterm birth
Time Frame: At <34 and <37 weeks' gestation
Spontaneous preterm birth (SPB) includes preterm labor, preterm spontaneous rupture of membranes, preterm premature rupture of membranes (PPROM) and cervical weakness; it does not include indicated preterm delivery for maternal or fetal conditions.
At <34 and <37 weeks' gestation
Gestational age at delivery
Time Frame: at delivery
Gestational age at delivery
at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiu Yee Liona Poon

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2019

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0434

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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