Postpartum Anxiety, Breastfeeding and Infant Health Among Taiwanese Women

NCT ID: NCT04608721

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 315 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-04
• Study Completion Date: 2023-01-10

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

Ditto

Conditions

Postpartum Anxiety; Breastfeeding; Infant Conditions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Postpartum Anxiety

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

PPA

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fu Jen Catholic University

OTHER

Sponsor Role: collaborator

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yuh-Kae Shyu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuh-Kae Shyu

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University

Locations

Fu Jen Catholic University

New Taipei City, Xinzhuang Dist, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yuh-Kae Shyu

Role: CONTACT

094528@mail.fju.edu.tw

886-2-29053500

Facility Contacts

Yuh-Kae Shyu, PhD

Role: primary

Other Identifiers

109-FJUH-12

Identifier Type: -

Identifier Source: org_study_id