Skip to main content
OpenTrials
Completed

NCT Number: NCT03941886

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Women and Children's Medical Center, Guangzhou, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low-dose aspirin in women with high risk of preeclampsia

Other

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 outcomes

  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 outcomes

  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

    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.

  6. 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.

    • 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. 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.

  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)

    Composite neonatal therapy (any one of the following): Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation.

  10. Gestational age at delivery

    Time frame: at delivery

    Gestational age at delivery

Sponsors and collaborators

Lead sponsor

Chiu Yee Liona Poon

Other

Registry information

Official study title

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

Acronym: FORECAST

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 8, 2019
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.