Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST) (FORECAST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03941886|
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : July 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pre-Eclampsia||Other: Low-dose aspirin in women with high risk of preeclampsia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52920 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||This is a stepped wedge cluster-randomized trial. There are total of 7 clusters across Asia. This study involves a period where no intervention will take place at all recruiting units, i.e. routine prenatal care, and then at regular intervals (every 6 weekly), 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 commencement of low-dose aspirin prophylaxis for high-risk women.|
|Masking:||None (Open Label)|
|Official Title:||Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||September 2022|
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
- Delivery with preterm-preeclampsia [ Time Frame: Before 37 weeks of gestation ]Proportions of delivery with preterm-preeclampsia between non-intervention and intervention groups
- 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
- 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.
- Low birth weight [ Time Frame: at birth ]Low birth weight <3rd, 5th and 10th percentile
- Stillbirth [ Time Frame: at or after 20 to 28 weeks of pregnancy ]Fetal death at or after 20 to 28 weeks of pregnancy
- Spontaneous preterm birth [ Time Frame: At <34 and <37 weeks' gestation ]
- The willingness of subjects accept to receive preeclampsia screening under the Bayes based method [ 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.
- The willingness of high-risk subjects to accept 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.
- 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.
- Composite neonatal therapy [ Time Frame: during the first 28 days of life (0-27 days) ]Neonatal high dependency or intensive care unit admission; Ventilation - need of positive pressure or intubation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941886
|Contact: Liona CY Prof Poon, MD||(852) 3505 firstname.lastname@example.org|
|Kunming Angel Women & Children Hospital||Not yet recruiting|
|Contact: Ruimei Ma, MD, PhD|
|Nanjing Drum Tower Hospital||Not yet recruiting|
|Contact: Yali Hu, MD|
|Kwong Wah Hospital||Not yet recruiting|
|Hong Kong, Hong Kong|
|Contact: Wing Cheong Leung, MD|
|Harapan Kita Hospital||Not yet recruiting|
|Contact: Aditya Kusuma|
|Clinical Research Institute of Fetal Medicine||Not yet recruiting|
|Contact: Ritsuko K Pooh|
|Showa University Hospital||Not yet recruiting|
|Contact: Akihiko Sekizawa|
|Japan Society for the Study of Hypertension in Pregnancy||Not yet recruiting|
|Contact: Shigeru Saito|
|Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre||Not yet recruiting|
|Bandar Tun Razak, Malaysia|
|Contact: Zaleha Abdullah Mahdy|
|Philippine General Hospital||Not yet recruiting|
|Contact: Angela Aguilar|
|National University Hospital||Active, not recruiting|
|Chang Gung Hospital||Not yet recruiting|
|Contact: Steven Shaw, MD|
|Taiji Clinic||Not yet recruiting|
|Contact: Tung-Yao Chang, MD|
|Chulalongkorn University Hospital||Not yet recruiting|
|Contact: Noppadol Chaiyasit, MD|
|Siriraj Hospital||Not yet recruiting|
|Contact: Tuangsit Wataganara, MD|
|Maharaj Nakorn Chiang Mai Hospital||Not yet recruiting|
|Chiang Mai, Thailand|
|Contact: Suchaya Luewan, MD, PhD|
|Thammasat University Hospital||Not yet recruiting|
|Khlong Luang, Thailand|
|Contact: Tongta Nanthakomon, MD|
|Hanoi Obstetrics & Gynecology Hospital||Not yet recruiting|
|Contact: Linh Dinh, MD|
|Principal Investigator:||Liona CY Poon, MD||Chinese University of Hong Kong|