EtiologyNCT02115438
A Cohort Study for Occupational Stress Induced Early Embryonic Death
An observational study of Etiology and Cohort Study, run by Peking University Third Hospital.
Trial summary
Occupation stress can be the risk factors of early embryonic death Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Etiology, Cohort Study, Early Embryonic Death
- How many people
- 3,405 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jan 2013
- 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: pregnant women with job
Who may be able to join
- Pregnant women and their spouses in the gynecology clinic patients and wish to create the cards in the hospital;
- the gestational age is less than 14 weeks;
- pregnant women and their spouses have jobs before treatment.
Who cannot join
- Do not sign the informed consent.
About this study
Occupation stress can be the risk factors of early embryonic death
- Conditions
- Etiology, Cohort Study, Early Embryonic Death, Occupational Stress, Occupational Epidemiology
- Medical subject headings
- Embryo Loss, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Stress | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
early embryonic death
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMar 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EtiologyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 3,405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiming Zhao, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115438
- Sponsor's protocol ID
- 54416-01
- Status last verified
- Apr 2014
- First submitted
- 14 Apr 2014
- Last updated
- 16 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study for Occupational Stress Induced Early Embryonic Death
- ClinicalTrials.gov ID
- NCT02115438
- Acronym / sponsor ID
- 54416-01
- Conditions
- Etiology, Cohort Study, Early Embryonic Death, Occupational Stress, Occupational Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,405 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Apr 2014 (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.
Occupation stress can be the risk factors of early embryonic death
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occupational Stress | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women with job
Key inclusion criteria (3 listed)
- Pregnant women and their spouses in the gynecology clinic patients and wish to create the cards in the hospital;
- the gestational age is less than 14 weeks;
- pregnant women and their spouses have jobs before treatment.
Key exclusion criteria (1 listed)
- Do not sign the informed consent.
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
early embryonic death
Time frame: 20 weeks
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 16 Apr 2014.
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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 Etiology and Cohort Study, run by Peking University Third 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 3 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: finished, as of the sponsor's last update on 16 Apr 2014. 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?
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?
early embryonic death (time frame: 20 weeks). 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 16 Apr 2014.