Postpartum Anxiety, Breastfeeding and Infant Health Among Taiwanese Women

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infant Conditions; Breastfeeding; Postpartum Anxiety
• Intervention / Treatment: Other: Postpartum Anxiety

Detailed Description

Ditto

• Study Type: Observational
• Enrollment (Anticipated): 315

Contacts and Locations

• Study Contact: Name: Yuh-Kae Shyu; Phone Number: 886-2-29053500; Email: 094528@mail.fju.edu.tw

Study Locations

• Taiwan
  • Xinzhuang Dist
    • New Taipei City, Xinzhuang Dist, Taiwan, 24205
      • Recruiting
      • Fu Jen Catholic University
      • Contact: Yuh-Kae Shyu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The subjects will be recruited in 1-3 days postpartum from the birth center or the postpartum ward in the hospitals in northern Taiwan. The well-trained research assistant/registered nurse, responsible for data collection, recognized potential subjects from their medical records, contacted the women and after explaining the aim of study, invited them to complete the baseline questionnaire.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	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.; Other Names: PPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum anxiety	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms	Baseline
Postpartum anxiety	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms	One month from baseline
Postpartum anxiety	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms	Three months from baseline
Postpartum anxiety	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms	Six months from baseline
Postpartum anxiety	Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms	Twelve months from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant health outcomes	Including breastfeeding patterns, excessive crying and body weight growth	Baseline
Infant health outcomes	Including breastfeeding patterns, excessive crying and body weight growth	One month from baseline
Infant health outcomes	Including breastfeeding patterns, excessive crying and body weight growth	Three months from baseline
Infant health outcomes	Including breastfeeding patterns, excessive crying and body weight growth	Six months from baseline
Infant health outcomes	Including breastfeeding patterns, excessive crying and body weight growth	Twelve months from baseline

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology, Taiwan
• Collaborators: Fu Jen Catholic University
• Investigators: Principal Investigator: Yuh-Kae Shyu, Fu Jen Catholic University

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Actual): November 30, 2021
• Study Completion (Anticipated): January 10, 2023

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 109-FJUH-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No