Perinatal DepressionNCT06231602
The Relationship Between Maternal Perinatal Depression and Feeding Behavior Among Primiparas
An observational study of Perinatal Depression and Breastfeeding, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this observational study is to explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, Breastfeeding, Complementary Feeding
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Feb 2024to 31 Dec 2026
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: It is planned to recruit participants at the Obstetrics and Gynecology Clinic of National Taiwan University Hospital. At the same time, research recruitment advertisements will also be posted online.
Who may be able to join
- Primipara
- Adult women over 18 years old
- Those with no recurrent pregnancy loss and stable signs of pregnancy
- Those who agree to participate in this study
Who cannot join
- No exclusion conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
HUNG-HUI CHEN, +886-2-23947109, hunghuichen@ntu.edu.tw
About this study
The goal of this observational study is to explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding. Participants will be asked to finish questionnaires four times (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum).
Read the detailed description
Background: Perinatal depression and infant feeding (breastfeeding and complementary feeding) are important global health issues. The prevalence of perinatal depression is high around the world, and breastfeeding rates in middle- and high-income countries are on a downward trend. Past research has pointed out that perinatal depression is related to infant feeding. However, there is a lack of research on the impact of maternal depression on infant feeding in Asian Chinese pregnant women, and "whether there is a bidirectional causal relationship between postpartum depression and infant feeding" remains unclear.
Purpose: To explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding.
Method: This is a longitudinal cohort study. It's estimated to recruit 500 pregnant women. It is planned to recruit participants at the Obstetrics and Gynecology Clinic of National Taiwan University Hospital. At the same time, research recruitment advertisements will also be posted online. This study will collect data by questionnaires distributed a total four times (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum). Variables include: sociodemographics, maternal variables (parity, number of births, planned pregnancy, maternal complications, mode of delivery, height and weight during pregnancy and postpartum, blood pressure), infant variables (gender, health status , height, weight), anticipatory feeding schedule, health-risk behaviors (smoking and alcohol use), social support, situation of breastfeeding and complementary feeding, reactive feeding, sleep, fatigue, exercise habits, and tendency to depression.
- Conditions
- Perinatal Depression, Breastfeeding, Complementary Feeding
- Keywords
- prenatal depression, postpartum depression, breastfeeding, complementary feeding
- Medical subject headings
- Breast Feeding, Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal variables
Questions contain parity, number of births, planned pregnancy, maternal complications, mode of delivery, height in centimeters, weight in kilograms, blood pressure, etc. Height and weight will be measured during pregnancy and postpartum(Height and weight will be combined to report BMI in kg/m^2).
Measured: 24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum
infant variables
Questions contain gender, health status , height in centimeters, weight in grams.
Measured: 2 month postpartum, 4 month postpartum, 6 month postpartum
perinatal depression
Depression was measured using the Edinburgh Postnatal Depression Scale.
Measured: 24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum
breastfeeding situation
Questions contain whether breastfeeding is continued, the type of feeding (breastfeeding or formula feeding), whether additional liquids are fed and the amount of feeding, etc.
Measured: 2 month postpartum, 4 month postpartum, 6 month postpartum
complementary feeding situation
Questions contain types of food, starting age of introduction, daily feeding amount and daily feeding times, etc.
Measured: 4 month postpartum, 6 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start19 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HUNG-HUI CHEN, Principal investigator, National Taiwan University Hostiptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231602
- Sponsor's protocol ID
- 202310157RINC
- Status last verified
- Nov 2025
- First submitted
- 21 Jan 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Maternal Perinatal Depression and Feeding Behavior Among Primiparas
- ClinicalTrials.gov ID
- NCT06231602
- Acronym / sponsor ID
- 202310157RINC
- Conditions
- Perinatal Depression, Breastfeeding, Complementary Feeding
- Keywords
- prenatal depression, postpartum depression, breastfeeding, complementary feeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2024 (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 goal of this observational study is to explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding. Participants will be asked to finish questionnaires four times (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum).
Detailed description
Background: Perinatal depression and infant feeding (breastfeeding and complementary feeding) are important global health issues. The prevalence of perinatal depression is high around the world, and breastfeeding rates in middle- and high-income countries are on a downward trend. Past research has pointed out that perinatal depression is related to infant feeding. However, there is a lack of research on the impact of maternal depression on infant feeding in Asian Chinese pregnant women, and "whether there is a bidirectional causal relationship between postpartum depression and infant feeding" remains unclear.
Purpose: To explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding.
Method: This is a longitudinal cohort study. It's estimated to recruit 500 pregnant women. It is planned to recruit participants at the Obstetrics and Gynecology Clinic of National Taiwan University Hospital. At the same time, research recruitment advertisements will also be posted online. This study will collect data by questionnaires distributed a total four times (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum). Variables include: sociodemographics, maternal variables (parity, number of births, planned pregnancy, maternal complications, mode of delivery, height and weight during pregnancy and postpartum, blood pressure), infant variables (gender, health status , height, weight), anticipatory feeding schedule, health-risk behaviors (smoking and alcohol use), social support, situation of breastfeeding and complementary feeding, reactive feeding, sleep, fatigue, exercise habits, and tendency to depression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to recruit participants at the Obstetrics and Gynecology Clinic of National Taiwan University Hospital. At the same time, research recruitment advertisements will also be posted online.
Key inclusion criteria (4 listed)
- Primipara
- Adult women over 18 years old
- Those with no recurrent pregnancy loss and stable signs of pregnancy
- Those who agree to participate in this study
Key exclusion criteria (1 listed)
- No exclusion conditions
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 variables
Time frame: 24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum
Questions contain parity, number of births, planned pregnancy, maternal complications, mode of delivery, height in centimeters, weight in kilograms, blood pressure, etc. Height and weight will be measured during pregnancy and postpartum(Height and weight will be combined to report BMI in kg/m^2).
infant variables
Time frame: 2 month postpartum, 4 month postpartum, 6 month postpartum
Questions contain gender, health status , height in centimeters, weight in grams.
perinatal depression
Time frame: 24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum
Depression was measured using the Edinburgh Postnatal Depression Scale.
breastfeeding situation
Time frame: 2 month postpartum, 4 month postpartum, 6 month postpartum
Questions contain whether breastfeeding is continued, the type of feeding (breastfeeding or formula feeding), whether additional liquids are fed and the amount of feeding, etc.
complementary feeding situation
Time frame: 4 month postpartum, 6 month postpartum
Questions contain types of food, starting age of introduction, daily feeding amount and daily feeding times, etc.
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 19 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Perinatal Depression
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Improving Perinatal Mental Health Through a Collaborative, Community Health Worker and Social Worker Intervention
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Deconstructing Maternal Burdens: Doulas and the Community Unite for Health
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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.
HUNG-HUI CHEN principal investigator
National Taiwan University Hostiptal
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 Perinatal Depression and Breastfeeding, run by National Taiwan University 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 4 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. 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?
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 HUNG-HUI CHEN (886-2-2394-7109, hunghuichen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal variables (time frame: 24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum). The study lists 5 primary outcomes in all. 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 19 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.