Pre-EclampsiaFORECASTNCT03941886
Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)
A study testing Low-dose aspirin in women with high risk of preeclampsia in people with Pre-Eclampsia, run by Chiu Yee Liona Poon at 19 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Low-dose aspirin in women with high risk of preeclampsia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42,454 participants
- Where
- 19 sitesin 10 countries
- Study dates
- 31 Jul 2019to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancy;
- Live fetus;
Who cannot join
- Multiple pregnancy;
- Major fetal defects identified at 11-13 weeks of assessment;
- Non-viable fetus (missed spontaneous abortion or stillbirth).
Trial locations and contacts
19 sites in 10 countries.
19 sites in 10 countries
Thailand4 sites
Chulalongkorn University Hospital
Bangkok
Siriraj Hospital
Bangkok
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
Thammasat University Hospital
Khlong Luang
China3 sites
Guangzhou Women and Children's Medical Center
Guangzhou
Kunming Angel Women & Children Hospital
Kunming
Nanjing Drum Tower Hospital
Nanjing
Japan3 sites
Clinical Research Institute of Fetal Medicine
Osaka
Showa University Hospital
Tokyo
Japan Society for the Study of Hypertension in Pregnancy
Toyama
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong, Hong Kong, China, Shatin
Kwong Wah Hospital
Hong Kong
Malaysia1 site
Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre
Bandar Tun Razak
About this study
Official title: 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.
- Conditions
- Pre-Eclampsia
- Being tested
- Low-dose aspirin in women with high risk of preeclampsia
- Keywords
- Pre-Eclampsia, Aspirin
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose aspirin in women with high risk of preeclampsiaOther
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
| Study group | Role | What they receive |
|---|---|---|
| Non-intervention group | No intervention | Participants receive routine prenatal care |
| Intervention group | Experimental | 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. Receives: Other: Low-dose aspirin in women with high risk of preeclampsia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery with preterm-preeclampsia
Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups
Measured: Before 37 weeks of gestation
Secondary outcomes (10)
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
Measured: 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.
Measured: during the first 28 days of life (0-27 days)
Low birth weight
Low birth weight <3rd, 5th and 10th percentile
Measured: at birth
Stillbirth
Fetal death at or after 20 to 28 weeks of pregnancy
Measured: 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.
Measured: 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.
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: during the first 28 days of life (0-27 days)
Gestational age at delivery
Gestational age at delivery
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start31 Jul 2019
- Primary completion15 Jun 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 42,454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiu Yee Liona Poon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chiu Yee Liona Poon, Chinese University of Hong Kong
- Investigators
- Liona CY Poon, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941886
- Sponsor's protocol ID
- 2018-0434
- Acronym
- FORECAST
- Status last verified
- Nov 2023
- First submitted
- 19 Dec 2018
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geographic variation in the incidence of hypertension in pregnancy. World Health Organization International Collaborative Study of Hypertensive Disorders of Pregnancy. Am J Obstet Gynecol. 1988 Jan;158(1):80-3.
PubMed 2962500Steegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2.
PubMed 20598363Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.
PubMed 16581405Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
PubMed 24150027Tranquilli AL, Dekker G, Magee L, Roberts J, Sibai BM, Steyn W, Zeeman GG, Brown MA. The classification, diagnosis and management of the hypertensive disorders of pregnancy: A revised statement from the ISSHP. Pregnancy Hypertens. 2014 Apr;4(2):97-104. doi: 10.1016/j.preghy.2014.02.001. Epub 2014 Feb 15. No abstract available.
PubMed 26104417National Collaborating Centre for Women's and Children's Health (UK). Hypertension in Pregnancy: The Management of Hypertensive Disorders During Pregnancy. London: RCOG Press; 2010 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK62652/
PubMed 22220321Committee Opinion No. 638: First-Trimester Risk Assessment for Early-Onset Preeclampsia. Obstet Gynecol. 2015 Sep;126(3):e25-e27. doi: 10.1097/AOG.0000000000001049.
PubMed 26287789Wright D, Syngelaki A, Akolekar R, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal characteristics and medical history. Am J Obstet Gynecol. 2015 Jul;213(1):62.e1-62.e10. doi: 10.1016/j.ajog.2015.02.018. Epub 2015 Feb 25.
PubMed 25724400O'Gorman N, Wright D, Syngelaki A, Akolekar R, Wright A, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 11-13 weeks gestation. Am J Obstet Gynecol. 2016 Jan;214(1):103.e1-103.e12. doi: 10.1016/j.ajog.2015.08.034. Epub 2015 Aug 19.
PubMed 26297382O'Gorman N, Wright D, Poon LC, Rolnik DL, Syngelaki A, de Alvarado M, Carbone IF, Dutemeyer V, Fiolna M, Frick A, Karagiotis N, Mastrodima S, de Paco Matallana C, Papaioannou G, Pazos A, Plasencia W, Nicolaides KH. Multicenter screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation: comparison with NICE guidelines and ACOG recommendations. Ultrasound Obstet Gynecol. 2017 Jun;49(6):756-760. doi: 10.1002/uog.17455.
PubMed 28295782Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.
PubMed 28657417Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.
PubMed 18634131Poon LC, Zymeri NA, Zamprakou A, Syngelaki A, Nicolaides KH. Protocol for measurement of mean arterial pressure at 11-13 weeks' gestation. Fetal Diagn Ther. 2012;31(1):42-8. doi: 10.1159/000335366. Epub 2012 Jan 13.
PubMed 22248988Chen Y, Nguyen-Hoang L, Dinh LT, Nguyen DA, Pooh RK, Shiozaki A, Zheng M, Hu Y, Ma R, Kusuma A, Wataganara T, Choolani MA, Kaneko M, Luewan S, Chang TY, Chaiyasit N, Nanthakomon T, Jiang Y, Shaw SW, Leung WC, Mohamad AS, Aguilar A, Lau SL, Lee NMW, Liu J, Sahota DS, Chong MKC, Papastefanou I, Poon LC. Effect of aspirin on small for gestational age neonates in pregnancies at high-risk for preeclampsia: a secondary analysis of a cluster randomised clinical trial. Lancet Reg Health West Pac. 2025 Jun 5;59:101582. doi: 10.1016/j.lanwpc.2025.101582. eCollection 2025 Jun.
PubMed 40529816Nguyen-Hoang L, Dinh LT, Tai AST, Nguyen DA, Pooh RK, Shiozaki A, Zheng M, Hu Y, Li B, Kusuma A, Yapan P, Gosavi A, Kaneko M, Luewan S, Chang TY, Chaiyasit N, Nanthakomon T, Liu H, Shaw SW, Leung WC, Mahdy ZA, Aguilar A, Leung HHY, Lee NMW, Lau SL, Wah IYM, Lu X, Sahota DS, Chong MKC, Poon LC; FORECAST Collaborators. Implementation of First-Trimester Screening and Prevention of Preeclampsia: A Stepped Wedge Cluster-Randomized Trial in Asia. Circulation. 2024 Oct 15;150(16):1223-1235. doi: 10.1161/CIRCULATIONAHA.124.069907. Epub 2024 Jun 26.
PubMed 38923439
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
- ClinicalTrials.gov ID
- NCT03941886
- Acronym / sponsor ID
- FORECAST / 2018-0434
- Conditions
- Pre-Eclampsia
- Keywords
- Pre-Eclampsia, Aspirin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42,454 participants (actual)
- Lead sponsor
- Chiu Yee Liona PoonUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-intervention group | No intervention | –Participants receive routine prenatal care |
| Intervention group | Experimental | Other: Low-dose aspirin in women with high risk of preeclampsiaParticipants receive first-trimester screening for preterm-preeclampsia by the Bayes based method followed by commencement of low-dose aspirin prophylaxis in high-risk women. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Singleton pregnancy;
- Live fetus;
Key exclusion criteria (3 listed)
- Multiple pregnancy;
- Major fetal defects identified at 11-13 weeks of assessment;
- Non-viable fetus (missed spontaneous abortion or stillbirth).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose aspirin in women with high risk of preeclampsiaLow-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 | Other | Intervention group |
Primary outcome
Delivery with preterm-preeclampsia
Time frame: Before 37 weeks of gestation
Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups
10 secondary outcomes
Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation
Time frame: at <34, <37 and ≥37 weeks of gestation
Neonatal mortality
Time frame: during the first 28 days of life (0-27 days)
Low birth weight
Time frame: at birth
Stillbirth
Time frame: at or after 20 to 28 weeks of pregnancy
Spontaneous preterm birth
Time frame: At <34 and <37 weeks' gestation
Acceptability for PE screening
Time frame: 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
Composite neonatal morbidity
Time frame: during the first 28 days of life (0-27 days)
Composite neonatal therapy
Time frame: during the first 28 days of life (0-27 days)
Gestational age at delivery
Time frame: at delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 2962500Geographic variation in the incidence of hypertension in pregnancy. World Health Organization International Collaborative Study of Hypertensive Disorders of Pregnancy. Am J Obstet Gynecol. 1988 Jan;158(1):80-3.
- Background: PubMed 20598363Steegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2.
- Background: PubMed 16581405Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.
- Background: PubMed 24150027Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Background: PubMed 26104417Tranquilli AL, Dekker G, Magee L, Roberts J, Sibai BM, Steyn W, Zeeman GG, Brown MA. The classification, diagnosis and management of the hypertensive disorders of pregnancy: A revised statement from the ISSHP. Pregnancy Hypertens. 2014 Apr;4(2):97-104. doi: 10.1016/j.preghy.2014.02.001. Epub 2014 Feb 15. No abstract available.
- Background: PubMed 22220321National Collaborating Centre for Women's and Children's Health (UK). Hypertension in Pregnancy: The Management of Hypertensive Disorders During Pregnancy. London: RCOG Press; 2010 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK62652/
- Background: PubMed 26287789Committee Opinion No. 638: First-Trimester Risk Assessment for Early-Onset Preeclampsia. Obstet Gynecol. 2015 Sep;126(3):e25-e27. doi: 10.1097/AOG.0000000000001049.
- Background: PubMed 25724400Wright D, Syngelaki A, Akolekar R, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal characteristics and medical history. Am J Obstet Gynecol. 2015 Jul;213(1):62.e1-62.e10. doi: 10.1016/j.ajog.2015.02.018. Epub 2015 Feb 25.
- Background: PubMed 26297382O'Gorman N, Wright D, Syngelaki A, Akolekar R, Wright A, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 11-13 weeks gestation. Am J Obstet Gynecol. 2016 Jan;214(1):103.e1-103.e12. doi: 10.1016/j.ajog.2015.08.034. Epub 2015 Aug 19.
- Background: PubMed 28295782O'Gorman N, Wright D, Poon LC, Rolnik DL, Syngelaki A, de Alvarado M, Carbone IF, Dutemeyer V, Fiolna M, Frick A, Karagiotis N, Mastrodima S, de Paco Matallana C, Papaioannou G, Pazos A, Plasencia W, Nicolaides KH. Multicenter screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation: comparison with NICE guidelines and ACOG recommendations. Ultrasound Obstet Gynecol. 2017 Jun;49(6):756-760. doi: 10.1002/uog.17455.
- Background: PubMed 28657417Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.
- Background: PubMed 18634131Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liona CY Poon, MD principal investigator
Chinese University of Hong Kong
19 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose aspirin in women with high risk of preeclampsia in people with Pre-Eclampsia, run by Chiu Yee Liona Poon at 19 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Thailand, China, Japan, Hong Kong, Taiwan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery with preterm-preeclampsia (time frame: Before 37 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941886, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.