Postpartum AnxietyNCT04608721
Postpartum Anxiety, Breastfeeding and Infant Health Among Taiwanese Women
An observational study of Postpartum Anxiety and Breastfeeding, run by Ministry of Science and Technology, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Anxiety, Breastfeeding, Infant Conditions
- What is being tested?
- Postpartum Anxiety
- How many people
- 315 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Nov 2020to 10 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 20-49 years old
- Primipara
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University
New Taipei City, Xinzhuang Dist, 24205
Yuh-Kae Shyu, PhD
About this study
Official title: Effects of Postpartum Anxiety on Breastfeeding and Infant Health Among Taiwanese Women: a Longitudinal Study
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
- Conditions
- Postpartum Anxiety, Breastfeeding, Infant Conditions
- Being tested
- Postpartum Anxiety
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum AnxietyOther
Also called PPA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Postpartum Anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum anxiety
Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms
Measured: Baseline
Postpartum anxiety
Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms
Measured: One month from baseline
Postpartum anxiety
Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms
Measured: Three months from baseline
Postpartum anxiety
Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms
Measured: Six months from baseline
Postpartum anxiety
Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms
Measured: Twelve months from baseline
Secondary outcomes (5)
Infant health outcomes
Including breastfeeding patterns, excessive crying and body weight growth
Measured: Baseline
Infant health outcomes
Including breastfeeding patterns, excessive crying and body weight growth
Measured: One month from baseline
Infant health outcomes
Including breastfeeding patterns, excessive crying and body weight growth
Measured: Three months from baseline
Infant health outcomes
Including breastfeeding patterns, excessive crying and body weight growth
Measured: Six months from baseline
Infant health outcomes
Including breastfeeding patterns, excessive crying and body weight growth
Measured: Twelve months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start4 Nov 2020
- Primary completion30 Nov 2021
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology, Taiwan
- Sponsor type
- Other government
- Collaborators
- Fu Jen Catholic University
- Responsible party
- Principal investigator, Yuh-Kae Shyu, Ministry of Science and Technology, Taiwan
- Investigators
- Yuh-Kae Shyu, Principal investigator, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608721
- Sponsor's protocol ID
- 109-FJUH-12
- Status last verified
- Jul 2022
- First submitted
- 22 Oct 2020
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postpartum Anxiety on Breastfeeding and Infant Health Among Taiwanese Women: a Longitudinal Study
- ClinicalTrials.gov ID
- NCT04608721
- Acronym / sponsor ID
- 109-FJUH-12
- Conditions
- Postpartum Anxiety, Breastfeeding, Infant Conditions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology, TaiwanOther government
- Collaborators
- Fu Jen Catholic University
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum Anxiety | – | Other: Postpartum AnxietyPostpartum 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). |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 20-49 years old
- Primipara
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum AnxietyAlso: PPAPostpartum 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 | Postpartum Anxiety |
Primary outcome
Postpartum anxiety
Time frame: Baseline
Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms
Postpartum anxiety
Time frame: One month from baseline
Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms
Postpartum anxiety
Time frame: Three months from baseline
Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms
Postpartum anxiety
Time frame: Six months from baseline
Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms
Postpartum anxiety
Time frame: Twelve months from baseline
Assessments using the Spielberger's State-Trait Anxiety Inventory (STAI) for self-reported anxiety symptoms
5 secondary outcomes
Infant health outcomes
Time frame: Baseline
Infant health outcomes
Time frame: One month from baseline
Infant health outcomes
Time frame: Three months from baseline
Infant health outcomes
Time frame: Six months from baseline
Infant health outcomes
Time frame: Twelve months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuh-Kae Shyu principal investigator
Fu Jen Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Anxiety and Breastfeeding, run by Ministry of Science and Technology, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuh-Kae Shyu (886-2-29053500, 094528@mail.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum anxiety (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.