ClinicalTrials.gg
Status unknownNCT04608721Updated Jul 25, 2022

Postpartum Anxiety, Breastfeeding and Infant Health Among Taiwanese Women

An observational study in Postpartum Anxiety, Breastfeeding and Infant Conditions, sponsored by Ministry of Science and Technology, Taiwan. Status unknown at 1 site in Taiwan. Open to female participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-25.

Sponsored by Ministry of Science and Technology, Taiwan · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
315
Ages
20 Years to 49 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 14 studies in Breast Feeding with a site in Taiwan — 1 open to participants now, 4 under way, none of them phase 3. Breast Feeding · Taiwan.

Started
2020
the only one that year
Observational
4 of 14
1 open now
Registered
6th of 14
by date
Lead sponsor
1 of 14
Ministry of Science and Technology, Taiwan

Among the 14 studies in Breast Feeding with a site in Taiwan, this one is the only one that started in 2020, is one of 4 observational ones, and was the 6th registered.

Breast Feeding

1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.

Browse Breast Feeding studies →

Open to participants now

1 of the 14 studies in Breast Feeding with a site in Taiwan is open now. Recruiting first, the newest first:

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 128 Breast Feeding studies recruiting now, 67 (52%) set no upper age limit and 59 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.

This study: 20 Years to 49 Years · female · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 14 studies in Breast Feeding with a site in Taiwan, or all of them as a file.
02

Study 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.

Read the detailed description

Ditto

03

Conditions studied

  • Postpartum Anxiety
  • Breastfeeding
  • Infant Conditions

Browse trials for

04

Who can participate

Ages eligible
20 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 20-49 years old
  • Primipara

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
315 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherPostpartum 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.

    Also known as: PPA

06

What researchers measure

Primary outcomes

  1. Postpartum anxiety

    Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms

    Time frame: Baseline

  2. Postpartum anxiety

    Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms

    Time frame: One month from baseline

  3. Postpartum anxiety

    Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms

    Time frame: Three months from baseline

  4. Postpartum anxiety

    Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms

    Time frame: Six months from baseline

  5. Postpartum anxiety

    Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms

    Time frame: Twelve months from baseline

Secondary outcomes

  1. Infant health outcomes

    Including breastfeeding patterns, excessive crying and body weight growth

    Time frame: Baseline

  2. Infant health outcomes

    Including breastfeeding patterns, excessive crying and body weight growth

    Time frame: One month from baseline

  3. Infant health outcomes

    Including breastfeeding patterns, excessive crying and body weight growth

    Time frame: Three months from baseline

  4. Infant health outcomes

    Including breastfeeding patterns, excessive crying and body weight growth

    Time frame: Six months from baseline

  5. Infant health outcomes

    Including breastfeeding patterns, excessive crying and body weight growth

    Time frame: Twelve months from baseline

07

Study locations

1 of 1 sites recruiting
  • Fu Jen Catholic University
    New Taipei City, Xinzhuang Dist 24205, Taiwan
    Recruiting
    • Yuh-Kae Shyu, PhD · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2020 to primary completion in Nov 2021, 12 months.

Of 86 non-industry observational studies under Breast Feeding, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 54. This study's 12 months is below that.

Counting every sponsor, half of 96 studies reached it within 33 months; a quarter within 19 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2020
First posted
Oct 29, 2020
StartActual
Nov 4, 2020
Primary completionActual
Nov 30, 2021
CompletionEst.
Jan 10, 2023
Last update
Jul 25, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04608721
Lead sponsor
Ministry of Science and Technology, Taiwan
Collaborators
Fu Jen Catholic University
Responsible party
Yuh-Kae Shyu (Assistant Professor, Ministry of Science and Technology, Taiwan) — Principal investigator
First posted
Oct 29, 2020
Start date
Nov 4, 2020
Primary completion
Nov 30, 2021
Completion
Jan 10, 2023 (estimated)
Last update
Jul 25, 2022

Study contacts

Yuh-Kae Shyu
Contact
094528@mail.fju.edu.tw
886-2-29053500
Yuh-Kae Shyu
principal investigator · Fu Jen Catholic University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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