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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06231602
Other study ID # 202310157RINC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source National Taiwan University Hospital
Contact HUNG-HUI CHEN
Phone 011-886-2-2394-7109
Email hunghuichen@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - No exclusion conditions

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum
Primary infant variables Questions contain gender, health status , height in centimeters, weight in grams. 2 month postpartum, 4 month postpartum, 6 month postpartum
Primary perinatal depression Depression was measured using the Edinburgh Postnatal Depression Scale. 24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum
Primary 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. 2 month postpartum, 4 month postpartum, 6 month postpartum
Primary complementary feeding situation Questions contain types of food, starting age of introduction, daily feeding amount and daily feeding times, etc. 4 month postpartum, 6 month postpartum
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