Postpartum Anxiety, Breastfeeding and Infant Health Among Taiwanese Women

• Conditions: Infant Conditions; Postpartum Anxiety; Breastfeeding
• Interventions: Other: Postpartum Anxiety

• Registration Number: NCT04608721
• Lead Sponsor: Ministry of Science and Technology, Taiwan

Brief 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.

Detailed Description

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Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-29
• Study Start: 2020-11-04
• Primary Completion: 2021-11-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-25
• Study Completion: 2023-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 315

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postpartum Anxiety	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).

Primary Outcome Measures

Name	Time	Method
Postpartum anxiety	Twelve months from baseline	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms

Secondary Outcome Measures

Name	Time	Method
Infant health outcomes	Twelve months from baseline	Including breastfeeding patterns, excessive crying and body weight growth

Trial Locations

Locations (1)

Fu Jen Catholic University; 🇨🇳 New Taipei City, Xinzhuang Dist, Taiwan