Postpartum Anxiety, Breastfeeding and Infant Health Among Taiwanese Women

Breastfeeding Clinical Trial

Official title:

Effects of Postpartum Anxiety on Breastfeeding and Infant Health Among Taiwanese Women: a Longitudinal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608721
• Other study ID #: 109-FJUH-12
• Status: Recruiting
• Start date: November 4, 2020
• Est. completion date: January 10, 2023

Study information

• Verified date: July 2022
• Source: Ministry of Science and Technology, Taiwan
• Contact: Yuh-Kae Shyu
• Phone: 886-2-29053500
• Email: 094528[@]mail.fju.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, longitudinal and observational study designed to investigate the trajectories of postpartum anxiety and its determinants in the first year after childbirth. This study also examine the associations between postpartum anxiety and infant health outcome, including breastfeeding patterns, excessive crying and body weight growth. Primipara aged 20-49 with term baby will be invited. Demographics, maternal-newborn characteristics, and anxiety symptoms will be collected during the first week postpartum (T1). Questionnaires will be follow-up by mail and telephone reminder in 1 (T2), 3 (T3), 6 (T4) and 12 months (T5) postpartum. The primary outcome is postpartum anxiety using the Spielberger's State-Trait Anxiety Inventory (STAI); the secondary outcomes are infant health outcomes including breastfeeding patterns, excessive crying and body weight growth. A linear mixed model (LMM) is used to determine the trajectories of postpartum anxiety over time and to examine whether specific demographic and maternal characteristics predict the trajectories of postpartum anxiety. The key findings may contribute to promote early identification and secondary preventive interventions for women with postpartum anxiety.

Description:

Ditto

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: January 10, 2023
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

Inclusion Criteria:

• 20-49 years old
• Primipara

Exclusion Criteria:

• Preterm birth
• Infants with severe congenital malformations/medical conditions or Fetal/neonatal death
• Current use of antidepressant or antipsychotics
• Thoughts of self-harm or suicide

Related Conditions & MeSH terms

• Anxiety Disorders
• Breastfeeding
• Infant Conditions
• Postpartum Anxiety

Intervention

Other:
• Postpartum Anxiety
Postpartum anxiety will be assessed at 1-3 days (T1), 1(T2), 3 (T3), 6 (T4) and 12 months (T5) postpartum by using the State-Trait Anxiety Inventory (STAI) with a score =40 serving as a positive screen.

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University	New Taipei City	Xinzhuang Dist

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Science and Technology, Taiwan	Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum anxiety	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms	Baseline
Primary	Postpartum anxiety	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms	One month from baseline
Primary	Postpartum anxiety	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms	Three months from baseline
Primary	Postpartum anxiety	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms	Six months from baseline
Primary	Postpartum anxiety	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms	Twelve months from baseline
Secondary	Infant health outcomes	Including breastfeeding patterns, excessive crying and body weight growth	Baseline
Secondary	Infant health outcomes	Including breastfeeding patterns, excessive crying and body weight growth	One month from baseline
Secondary	Infant health outcomes	Including breastfeeding patterns, excessive crying and body weight growth	Three months from baseline
Secondary	Infant health outcomes	Including breastfeeding patterns, excessive crying and body weight growth	Six months from baseline
Secondary	Infant health outcomes	Including breastfeeding patterns, excessive crying and body weight growth	Twelve months from baseline