Postpartum Anxiety, Breastfeeding and Infant Health Among Taiwanese Women

Sponsor

Ministry of Science and Technology, Taiwan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04608721

Collaborator

Fu Jen Catholic University (Other)

315

Enrollment

Location

26.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Anxiety Breastfeeding Infant Conditions	Other: Postpartum Anxiety

Detailed Description

Ditto

Study Design

Study Type:

Observational

Anticipated Enrollment :

315 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 4, 2020

Actual Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Jan 10, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Infant health outcomes [Baseline]
Including breastfeeding patterns, excessive crying and body weight growth
Infant health outcomes [One month from baseline]
Including breastfeeding patterns, excessive crying and body weight growth
Infant health outcomes [Three months from baseline]
Including breastfeeding patterns, excessive crying and body weight growth
Infant health outcomes [Six months from baseline]
Including breastfeeding patterns, excessive crying and body weight growth
Infant health outcomes [Twelve months from baseline]
Including breastfeeding patterns, excessive crying and body weight growth

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fu Jen Catholic University	New Taipei City	Xinzhuang Dist	Taiwan	24205

Sponsors and Collaborators

Ministry of Science and Technology, Taiwan
Fu Jen Catholic University

Investigators

Principal Investigator: Yuh-Kae Shyu, Fu Jen Catholic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yuh-Kae Shyu, Assistant Professor, Ministry of Science and Technology, Taiwan

ClinicalTrials.gov Identifier:

NCT04608721

Other Study ID Numbers:

109-FJUH-12

First Posted:

Oct 29, 2020

Last Update Posted:

Jul 25, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Jul 25, 2022