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

Chiu Yee Liona Poon42,454 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

42,454

Conditions

Pre-Eclampsia

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (19)

Guangzhou Women and Children's Medical Center

Guangzhou, China

Kunming Angel Women & Children Hospital

Kunming, China

Nanjing Drum Tower Hospital

Nanjing, China

Prince of Wales Hospital

Hong Kong, Hong Kong, China, Hong Kong

Kwong Wah Hospital

Hong Kong, Hong Kong

Harapan Kita Hospital

Jakarta, Indonesia

Clinical Research Institute of Fetal Medicine

Osaka, Japan

Showa University Hospital

Tokyo, Japan

Japan Society for the Study of Hypertension in Pregnancy

Toyama, Japan

Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre

Bandar Tun Razak, Malaysia

...and 9 more locations

Outcomes

Primary Outcomes

Delivery with preterm-preeclampsia

Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups

Time frame: Before 37 weeks of gestation

Secondary Outcomes

Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation

including preeclampsia, gestational hypertension, small for gestational age birth weight (\<5th percentile), stillbirth, placental abruption

Time frame: at <34, <37 and ≥37 weeks of gestation

Neonatal mortality

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.

Time frame: during the first 28 days of life (0-27 days)

Low birth weight

Low birth weight \<3rd, 5th and 10th percentile

Time frame: at birth

Stillbirth

Fetal death at or after 20 to 28 weeks of pregnancy

Time frame: at or after 20 to 28 weeks of pregnancy

Spontaneous preterm birth

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.

Time frame: At <34 and <37 weeks' gestation

Acceptability for PE screening

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.

Time frame: in the first trimester of pregnancy (11-13 weeks of gestation)

Acceptability for aspirin treatment.

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.

Time frame: from <15 weeks till 36 weeks of gestation or, in the event of early delivery, at the onset of labor

Composite neonatal morbidity

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.

Time frame: during the first 28 days of life (0-27 days)

Composite neonatal therapy

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

Time frame: during the first 28 days of life (0-27 days)

Gestational age at delivery

Time frame: at delivery