Mental Disorder During Pregnancy - Baby Not Yet DeliveredNCT02026804
Prevalence ， Associated Factors and Influences of Prenatal Mental Disorders
An observational study of Mental Disorder During Pregnancy - Baby Not Yet Delivered, run by Zhejiang Provincial Natural Science Foundation of China at 1 site in China.
Trial summary
The purpose of this study is to find the incidence of mental disorders during different periods of pregnancy and its associated factors and consequences. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Mental Disorder During Pregnancy - Baby Not Yet Delivered
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2015
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women who had perinatal health care in a Women's \& Children's Health Hospital of zhejiang province, China
Who may be able to join
- Aged at least 18 years of age
- 8 to 12 weeks of pregnancy
- There is no history of mental illness
- Had perinatal health care in a Women's \& Children's Health Hospital
Who cannot join
- The obvious body disease
- Having anxiety, phobia, hypochondriasis, obsessive-compulsive disorder or depression before pregnancy
- Having severe complications during pregnancy
- Fetal malformation or abortion
- Can't understand the questionnaire
- Without informed consent
- More than 13 weeks of pregnancy
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhoushan Women's & Children's Health Hospital
Zhoushan, Zhejiang, 316000
Zhang, 86-580-2065188
Youding Zhang, MD
About this study
The purpose of this study is to find the incidence of mental disorders during different periods of pregnancy and its associated factors and consequences.
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 |
|---|---|---|
| Prenatal mental disorders | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of mental disorders during different periods of pregnancy
We would like to find the incidence of mental disorders in early (8-12 weeks),middle (18-22 weeks) and later(32 weeks to delivery) period of pregnancy
Measured: from 8 weeks of pregnancy to delivery
Secondary outcomes (1)
pregnancy outcomes
We would like to explore which period of mental disorders had the most significant infuences on pregnancy outcomes including obstetrical complications(e.g.gestational diabetes mellitus(GDM),hypertensive disorder complicating pregnancy(HDCP)),outcome of fetus(e.g.preterm,low birth weight and fetal anomaly) and health of infant and puerpera.
Measured: from 8 weeks of pregnancy to 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorder During Pregnancy - Baby Not Yet DeliveredStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Natural Science Foundation of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026804
- Sponsor's protocol ID
- Y21000505
- Status last verified
- Jan 2015
- First submitted
- 30 Dec 2013
- Last updated
- 22 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence ， Associated Factors and Influences of Prenatal Mental Disorders
- ClinicalTrials.gov ID
- NCT02026804
- Acronym / sponsor ID
- Y21000505
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Zhejiang Provincial Natural Science Foundation of ChinaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 3 Jan 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.
The purpose of this study is to find the incidence of mental disorders during different periods of pregnancy and its associated factors and consequences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prenatal mental disorders | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women who had perinatal health care in a Women's \& Children's Health Hospital of zhejiang province, China
Key inclusion criteria (4 listed)
- Aged at least 18 years of age
- 8 to 12 weeks of pregnancy
- There is no history of mental illness
- Had perinatal health care in a Women's \& Children's Health Hospital
Key exclusion criteria (8 listed)
- The obvious body disease
- Having anxiety, phobia, hypochondriasis, obsessive-compulsive disorder or depression before pregnancy
- Having severe complications during pregnancy
- Fetal malformation or abortion
- Can't understand the questionnaire
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
Incidence of mental disorders during different periods of pregnancy
Time frame: from 8 weeks of pregnancy to delivery
We would like to find the incidence of mental disorders in early (8-12 weeks),middle (18-22 weeks) and later(32 weeks to delivery) period of pregnancy
1 secondary outcome
pregnancy outcomes
Time frame: from 8 weeks of pregnancy to 6 months after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
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 Mental Disorder During Pregnancy - Baby Not Yet Delivered, run by Zhejiang Provincial Natural Science Foundation of China at 1 site in China.
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 4 inclusion and 8 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 22 Jan 2015. 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 China. 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 Youding Zhang, MD (86-580-2065188, tougaoing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of mental disorders during different periods of pregnancy (time frame: from 8 weeks of pregnancy to delivery). 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 22 Jan 2015.