DepressionNCT04499066
Peripartum Mental Health Cohort Study in Guangzhou
An observational study of Depression and Anxiety, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial summary
The purpose of this study is to determine the incidence,development trajectory and risk factors of the main peripartum mental health problems as well as explore its adverse outcomes. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2012to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women before 20 weeks of gestation
Who may be able to join
- Pregnant women with <20 weeks of gestation
- Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
- Permanent residents or families intended to remain in Guangzhou with their child for more than 3 years
Who cannot join
- Combined with heart disease, hypertension, diabetes or hyperthyroidism
- Taking anti-depressants and other treatments for depression
- Participants was in infection status when the biological samples were collected
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dongmei Wei, MSc contact
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
Xiu Qiu, PhD, qxiu0161@163.com
About this study
The purpose of this study is to determine the incidence,development trajectory and risk factors of the main peripartum mental health problems as well as explore its adverse outcomes.
Read the detailed description
Peripartum mental health problems (such as anxiety and depression), affecting more than 20% of mothers, is one of the most common complications around childbirth and gradually have become global public health issues. However, little is known about the course of peripartum mental health problems and possible fluctuations, as well as related risk factors among Chinese women. In addition, there are no effective prediction and preventive strategies for postpartum depression. The Peripartum Mental Health Cohort Study in Guangzhou will collect the epidemiological, clinical information and biological specimens across pregnancy and childbirth to establish trajectory of peripartum mental health and identify the factors influencing the fluctuations and build a comprehensive prediction model of postpartum depression, as well as explore its adverse outcomes. This study would help to determine the timing of screening and target interventions to improve women's and their offspring's health.
- Conditions
- Depression, Anxiety
- Keywords
- Peripartum, Mental health, Risk factors, Pregnancy outcome, Cohort
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of prevalence of maternal prenatal depression
Using Self-rating Depression Scale (SDS) to assess maternal depressive symptoms during pregnancy. SDS scores ≥53 is defined as prenatal depressive symptoms.
Measured: before 20th gestational week, after 33th gestational week and prior to delivery
Change of prevalence of maternal postpartum depression in the first year after delivery
Using Edinburgh Postnatal Depression Scale (EPDS) to assess postpartum depressive symptoms. EPDS scores ≥13 is defined as postpartum depressive symptoms.
Measured: 6 weeks, 6 months and 1 year after delivery
Secondary outcomes (5)
Change of prevalence of maternal anxiety during pregnancy
Using Self-rating Anxiety Scale (SAS) to assess maternal anxiety during pregnancy. SAS scores ≥50 is defined as anxiety.
Measured: before 20th gestational week, after 33th gestational week and prior to delivery
Level of maternal cortisol during pregnancy
Using women's blood samples to test the concentration of cortisol.
Measured: During period of 2-3 trimesters of pregnancy
Levels of maternal inflammatory factors during pregnancy
Using women's blood samples to test the concentration of inflammatory factors, including CRP, IL-6, TNF-α, etc.
Measured: During period of 2-3 trimesters of pregnancy
Prevalence of preterm birth, small for gestational age, low birth weight
Obtained from electronic medical records.
Measured: At delivery
Child's neurodevelopment at early childhood
Assessed by using the Gesell Developmental Schedules, which includes adaptive, gross motor, fine motor, language, and social function domains. Higher score in each domain is considered a better outcome, while no more than 85 is defined as suspected development delay.
Measured: At child's age of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Feb 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiu Qiu, Guangzhou Women and Children's Medical Center
- Investigators
- Xiu Qiu, PhD, Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499066
- Sponsor's protocol ID
- 2018053101
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.
PubMed 28321694
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripartum Mental Health Cohort Study in Guangzhou
- ClinicalTrials.gov ID
- NCT04499066
- Acronym / sponsor ID
- 2018053101
- Conditions
- Depression, Anxiety
- Keywords
- Peripartum, Mental health, Risk factors, Pregnancy outcome, Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 5 Aug 2020 (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.
The purpose of this study is to determine the incidence,development trajectory and risk factors of the main peripartum mental health problems as well as explore its adverse outcomes.
Detailed description
Peripartum mental health problems (such as anxiety and depression), affecting more than 20% of mothers, is one of the most common complications around childbirth and gradually have become global public health issues. However, little is known about the course of peripartum mental health problems and possible fluctuations, as well as related risk factors among Chinese women. In addition, there are no effective prediction and preventive strategies for postpartum depression. The Peripartum Mental Health Cohort Study in Guangzhou will collect the epidemiological, clinical information and biological specimens across pregnancy and childbirth to establish trajectory of peripartum mental health and identify the factors influencing the fluctuations and build a comprehensive prediction model of postpartum depression, as well as explore its adverse outcomes. This study would help to determine the timing of screening and target interventions to improve women's and their offspring's health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women before 20 weeks of gestation
Key inclusion criteria (3 listed)
- Pregnant women with <20 weeks of gestation
- Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
- Permanent residents or families intended to remain in Guangzhou with their child for more than 3 years
Key exclusion criteria (3 listed)
- Combined with heart disease, hypertension, diabetes or hyperthyroidism
- Taking anti-depressants and other treatments for depression
- Participants was in infection status when the biological samples were collected
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
Change of prevalence of maternal prenatal depression
Time frame: before 20th gestational week, after 33th gestational week and prior to delivery
Using Self-rating Depression Scale (SDS) to assess maternal depressive symptoms during pregnancy. SDS scores ≥53 is defined as prenatal depressive symptoms.
Change of prevalence of maternal postpartum depression in the first year after delivery
Time frame: 6 weeks, 6 months and 1 year after delivery
Using Edinburgh Postnatal Depression Scale (EPDS) to assess postpartum depressive symptoms. EPDS scores ≥13 is defined as postpartum depressive symptoms.
5 secondary outcomes
Change of prevalence of maternal anxiety during pregnancy
Time frame: before 20th gestational week, after 33th gestational week and prior to delivery
Level of maternal cortisol during pregnancy
Time frame: During period of 2-3 trimesters of pregnancy
Levels of maternal inflammatory factors during pregnancy
Time frame: During period of 2-3 trimesters of pregnancy
Prevalence of preterm birth, small for gestational age, low birth weight
Time frame: At delivery
Child's neurodevelopment at early childhood
Time frame: At child's age of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 28321694Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.
- 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.
Dongmei Wei, MSc contact
Xiu Qiu, PhD principal investigator
Guangzhou Women and Children's Medical Center
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 Depression and Anxiety, run by Guangzhou Women and Children's Medical Center 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 3 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: looking for participants now, as of the sponsor's last update on 13 Sep 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiu Qiu, PhD (0086 20 38367160, qxiu0161@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of prevalence of maternal prenatal depression (time frame: before 20th gestational week, after 33th gestational week and prior to delivery). The study lists 2 primary outcomes in all. 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 NCT04499066, which also lists 1 linked publication.
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 13 Sep 2023.