PreeclampsiaNCT01804751
Prediction of Adverse Perinatal Outcome for Preeclampsia in Sichuan Province of China
An observational study of Preeclampsia, run by West China Second University Hospital.
Trial summary
The purpose of this study is to build a model for the prediction of adverse perinatal outcome for preeclampsia in china Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese women who fulfilled a research definition of preeclampsia, and who were admitted to participating obstetric centres
Who may be able to join
- admitted with preeclampsia or had developed preeclampsia after admission
Who cannot join
- admitted in spontaneous labour or had achieved any component of the maternal outcome before either fulfilling eligibility criteria or collection of predictor data
About this study
The purpose of this study is to build a model for the prediction of adverse perinatal outcome for preeclampsia in china
- Conditions
- Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal mortality
Measured: within 48h of eligibility
Secondary outcomes (5)
serious central nervous system morbidity
Measured: within 48h of eligibility
serious cardiorespiratory morbidity
Measured: within 48h of eligibility
serious hepatic morbidity.
Measured: within 48h of eligibility
serious renal morbidity
Measured: within 48h of eligibility
serious haematological morbidity
Measured: within 48h of eligibility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Academy of Medical Sciences, Guang'an people's hospital of Sichuan province, The First People's Hospital of Neijiang, Suining Central Hospital, Sichuan Provincial Maternal and Child Health Care Hospital, Chengdu Women's and Children's Central Hospital, Luzhou Medical College, pengzhou shi fuyou baojianyuan, Nanchong Central Hospital
- Responsible party
- Principal investigator, Xinghui Liu, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804751
- Sponsor's protocol ID
- hx2ck2
- Status last verified
- Jun 2013
- First submitted
- 1 Mar 2013
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Adverse Perinatal Outcome for Preeclampsia in Sichuan Province of China
- ClinicalTrials.gov ID
- NCT01804751
- Acronym / sponsor ID
- hx2ck2
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Collaborators
- Sichuan Academy of Medical Sciences, Guang'an people's hospital of Sichuan province, The First People's Hospital of Neijiang, Suining Central Hospital, Sichuan Provincial Maternal and Child Health Care Hospital, Chengdu Women's and Children's Central Hospital, Luzhou Medical College, pengzhou shi fuyou baojianyuan, Nanchong Central Hospital
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 5 Mar 2013 (estimated)
- 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.
The purpose of this study is to build a model for the prediction of adverse perinatal outcome for preeclampsia in china
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese women who fulfilled a research definition of preeclampsia, and who were admitted to participating obstetric centres
Key inclusion criteria (1 listed)
- admitted with preeclampsia or had developed preeclampsia after admission
Key exclusion criteria (1 listed)
- admitted in spontaneous labour or had achieved any component of the maternal outcome before either fulfilling eligibility criteria or collection of predictor data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
maternal mortality
Time frame: within 48h of eligibility
5 secondary outcomes
serious central nervous system morbidity
Time frame: within 48h of eligibility
serious cardiorespiratory morbidity
Time frame: within 48h of eligibility
serious hepatic morbidity.
Time frame: within 48h of eligibility
serious renal morbidity
Time frame: within 48h of eligibility
serious haematological morbidity
Time frame: within 48h of eligibility
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by West China Second University Hospital.
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 1 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 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
maternal mortality (time frame: within 48h of eligibility). 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 25 Aug 2015.