Pre-eclampsiaNCT04021680
Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.
An observational study of Pre-eclampsia, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Pre-eclampsia
- What is being tested?
- pre-eclampsia screening program
- How many people
- 2,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jun 2019to 20 Jun 2025
- Phase
- Observational
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with with singleton pregnancy
Who may be able to join
- Women who are 20 years of age or older with singleton pregnancy between 11 to 13 + 6 weeks and received first trimester pre-eclampsia screening test in this institution.
Who cannot join
- Women who are not regularly inspected or not receiving prenatal care in this institution.
- Women who received first trimester pre-eclampsia screening test at other institution
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
Official title: Far Eastern Memorial Hospital
To evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.
Read the detailed description
The incidence of pre-eclampsia is about 2-8%, it is a leading cause of maternal and perinatal mortality and morbidity. Both ACOG (American Congress of Obstetricians and Gynecologists) and NICE (National Institute for Health and Clinical Excellence) guideline advocate the use of traditional screening method, which uses demographic characters and medical history to identify high risk women. This method detects only 35-40% of pre-eclampsia women. Study has shown that combination of maternal factors and biomarkers (uterine artery pulsatility index, placenta growth factor, PlGF; pregnancy associated plasma protein-A, PAPP-A) improves the detection rate.
In Taiwan, the prevalence of pre-eclampsia is about 1.21%. The incidence of pre-eclampsia is correlated with maternal age, with a relative risk of 5.13-fold in women aged 40 and above. Marrying late predisposes these women at high risk of developing pre-eclampsia. Our institution will be implementing first-trimester screening program starting from April 2019, this study aims to evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.
- Conditions
- Pre-eclampsia
- Being tested
- pre-eclampsia screening program
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-eclampsia screening programOther
This screening program included the use of ultrasound, biomarkers and maternal factors in calculating the risk of developing preeclampsia.
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of this screening program to detect preeclampsia
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start10 Jun 2019
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gynecologic Oncology Group
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021680
- Sponsor's protocol ID
- 108051-F
- Status last verified
- Mar 2023
- First submitted
- 14 Jul 2019
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Far Eastern Memorial Hospital
- ClinicalTrials.gov ID
- NCT04021680
- Acronym / sponsor ID
- 108051-F
- Conditions
- Pre-eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- Gynecologic Oncology Group
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 16 Jul 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.
To evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.
Detailed description
The incidence of pre-eclampsia is about 2-8%, it is a leading cause of maternal and perinatal mortality and morbidity. Both ACOG (American Congress of Obstetricians and Gynecologists) and NICE (National Institute for Health and Clinical Excellence) guideline advocate the use of traditional screening method, which uses demographic characters and medical history to identify high risk women. This method detects only 35-40% of pre-eclampsia women. Study has shown that combination of maternal factors and biomarkers (uterine artery pulsatility index, placenta growth factor, PlGF; pregnancy associated plasma protein-A, PAPP-A) improves the detection rate.
In Taiwan, the prevalence of pre-eclampsia is about 1.21%. The incidence of pre-eclampsia is correlated with maternal age, with a relative risk of 5.13-fold in women aged 40 and above. Marrying late predisposes these women at high risk of developing pre-eclampsia. Our institution will be implementing first-trimester screening program starting from April 2019, this study aims to evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with with singleton pregnancy
Key inclusion criteria (1 listed)
- Women who are 20 years of age or older with singleton pregnancy between 11 to 13 + 6 weeks and received first trimester pre-eclampsia screening test in this institution.
Key exclusion criteria (2 listed)
- Women who are not regularly inspected or not receiving prenatal care in this institution.
- Women who received first trimester pre-eclampsia screening test at other institution
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 |
|---|---|---|
| pre-eclampsia screening programThis screening program included the use of ultrasound, biomarkers and maternal factors in calculating the risk of developing preeclampsia. | Other | – |
Primary outcome
The sensitivity and specificity of this screening program to detect preeclampsia
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
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Preeclampsia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-eclampsia, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Mou Hsiao, MD (+88689667000 ext. 1818, smhsiao2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of this screening program to detect preeclampsia (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2023.