Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)
- Conditions
- Pre-Eclampsia
- Interventions
- Other: Low-dose aspirin in women with high risk of preeclampsia
- Registration Number
- NCT03941886
- Lead Sponsor
- Chiu Yee Liona Poon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42454
- Singleton pregnancy;
- Live fetus;
- Multiple pregnancy;
- Major fetal defects identified at 11-13 weeks of assessment;
- Non-viable fetus (missed spontaneous abortion or stillbirth).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention group Low-dose aspirin in women with high risk of preeclampsia 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.
- Primary Outcome Measures
Name Time Method Delivery with preterm-preeclampsia Before 37 weeks of gestation Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups
- Secondary Outcome Measures
Name Time Method Low birth weight at birth Low birth weight \<3rd, 5th and 10th percentile
Spontaneous preterm birth 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.
Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation at <34, <37 and ≥37 weeks of gestation including preeclampsia, gestational hypertension, small for gestational age birth weight (\<5th percentile), stillbirth, placental abruption
Gestational age at delivery at delivery Gestational age at delivery
Neonatal mortality 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.Stillbirth at or after 20 to 28 weeks of pregnancy Fetal death at or after 20 to 28 weeks of pregnancy
Acceptability for PE screening 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.Acceptability for aspirin treatment. 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.
Composite neonatal morbidity 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.
Composite neonatal therapy 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.
Trial Locations
- Locations (19)
Kunming Angel Women & Children Hospital
🇨🇳Kunming, China
Showa University Hospital
🇯🇵Tokyo, Japan
Siriraj Hospital
🇹🇭Bangkok, Thailand
Chang Gung Hospital
🇨🇳Taipei, Taiwan
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China
Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, China
Harapan Kita Hospital
🇮🇩Jakarta, Indonesia
Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre
🇲🇾Bandar Tun Razak, Malaysia
Hanoi Obstetrics & Gynecology Hospital
🇻🇳Hanoi, Vietnam
Japan Society for the Study of Hypertension in Pregnancy
🇯🇵Toyama, Japan
Clinical Research Institute of Fetal Medicine
🇯🇵Osaka, Japan
Philippine General Hospital
🇵🇭Manila, Philippines
National University Hospital
🇸🇬Singapore, Singapore
Chulalongkorn University Hospital
🇹🇭Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Chiang Mai, Thailand
Thammasat University Hospital
🇹🇭Khlong Luang, Thailand
Taiji Clinic
🇨🇳Taipei, Taiwan
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong, China, Hong Kong
Kwong Wah Hospital
🇭🇰Hong Kong, Hong Kong