NCT04608721

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

November 4, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

October 22, 2020

Last Update Submit

July 22, 2022

Conditions

Postpartum AnxietyBreastfeedingInfant Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Infant health outcomes

    Baseline

  • Infant health outcomes

    One month from baseline

  • Infant health outcomes

    Three months from baseline

  • Infant health outcomes

    Six months from baseline

  • Infant health outcomes

    Twelve months from baseline

Study Arms (1)

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

Interventions

Postpartum AnxietyOTHER

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.

Also known as: PPA
Postpartum Anxiety

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • years old
  • Primipara

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University

New Taipei City, Xinzhuang Dist, 24205, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Yuh-Kae Shyu

    Fu Jen Catholic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuh-Kae Shyu

CONTACT

886-2-29053500094528@mail.fju.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 29, 2020

Study Start

November 4, 2020

Primary Completion

November 30, 2021

Study Completion

January 10, 2023

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations

TW(1)