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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04608721
Other study ID # 109-FJUH-12
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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