Clinical trial NCT04608721: Postpartum Anxiety, Breastfeeding and Infant Health Among Taiwanese Women
Official title: Effects of Postpartum Anxiety on Breastfeeding and Infant Health Among Taiwanese Women: a Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum Anxiety
Breastfeeding
Infant Conditions
Lead sponsor: Ministry of Science and Technology, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Fu Jen Catholic University
First posted: 2020-10-29
Enrollment: 315
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Ditto

Eligibility criteria: 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

Primary outcomes:
measure: Postpartum anxiety
timeFrame: Baseline
measure: Postpartum anxiety
timeFrame: One month from baseline
measure: Postpartum anxiety
timeFrame: Three months from baseline
measure: Postpartum anxiety
timeFrame: Six months from baseline
measure: Postpartum anxiety
timeFrame: Twelve months from baseline
Secondary outcomes:
measure: Infant health outcomes
timeFrame: Baseline
measure: Infant health outcomes
timeFrame: One month from baseline
measure: Infant health outcomes
timeFrame: Three months from baseline
measure: Infant health outcomes
timeFrame: Six months from baseline
measure: Infant health outcomes
timeFrame: Twelve months from baseline
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University
state: Xinzhuang Dist
Study officials:
affiliation: Fu Jen Catholic University
name: Yuh-Kae Shyu
role: PRINCIPAL_INVESTIGATOR
References: