Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universidade Federal de Goias | OTHER |
| University of Wisconsin, Eau Claire | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This research is being done to understand better how a mother's emotional well-being and lifestyle, such as her levels of stress, fatigue, depression, anxiety, sleep quality, and eating habits, might affect the levels of melatonin and sIgA in her breast milk.
This study aims to learn more about promoting mothers' and babies' health by studying various maternal factors. Gaining a better understanding of the connections between a mother's emotional and physical state and the quality of her breast milk could lead to new recommendations and support strategies to improve the mother's well-being.
Participants will be involved in the study during the immediate postpartum period. They will be asked to provide a 5mL sample of breast milk on day 14 postpartum between 6am and 9am. Participants will be asked to use an orange ambient light during nighttime infant care from the time they come home from the hospital up until the time of breastmilk collection to avoid harsh lighting while providing care for their baby, which may affect melatonin levels.
In addition to breast milk collection, participants will complete a series of questionnaires related to their emotion well-being and lifestyle. These questionnaires will help the research team understand how factors like stress, fatigue, depression, anxiety, sleep, and dietary patterns may be associated with melatonin and sIgA levels in breast milk. Information regarding medications and gestational age of the newborn will be collected from medical records to further assist in data analysis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breasting Feeding Mothers | New mothers in the immediate postpartum period and breastfeeding their newborn will be asked to collect a sample of breast milk at 14 days postpartum between 6 am and 9 am. In addition to providing a breast milk sample, they will complete a series of questionnaires related to their emotional well-being and lifestyles. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Melatonin concentration in breast milk | Melatonin concentration in breast milk samples, reported in picograms per milliliter (pg/mL) | 14 days postpartum |
| sIgA concentration in breast milk | concentration in breast milk samples, reported in picograms per milliliter (pg/mL) | 14 days postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Symptoms | Measured using the 14-item Depression, Anxiety and Stress Scale that assesses negative emotional states. Possible total scores range from 0 to 42, with higher scores indicating more negative emotional state and worse outcome. | 14 days postpartum |
| Depression Symptoms |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
New mothers receiving care at Mayo Clinic Health System in Eau Claire, Wisconsin.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ganesh Namachivayam, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System - Eau Claire | Eau Claire | Wisconsin | 54703 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Breast milk.
Measured using the 10-item Edinburgh Depression Scale (EDS) that assesses depressive symptoms. Possible total scores range from 0 to 30, with higher scores indicating more depressive symptoms and a worse outcome. |
| 14 days postpartum |
| Fatigue | Measured using the 10-item Fatigue Assessment Scale that assesses symptoms of chronic fatigue. Possible total scores range from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue. | 14 days postpartum |
| Sleep Quality | Measured using the The Pittsburgh Sleep Quality Index that assesses the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance. | 14 days postpartum |