Study of Exposure to Stress, Postpartum Mood, Adverse Life Events, and Hormonal Function Among Latinas (SEPAH Latina)
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 2/7/2015 |
| Start Date: | August 2013 |
| End Date: | August 2016 |
Assessing the Association Between Stressful Life Events, Hormonal Dysregulation, and Postpartum Depression Among Lactating Latina Mothers: A Pilot Study
The purpose of the funded study is to determine a) examine associations among OT levels,
stress, trauma history, PPD, and lactation failure in the full 60-subject sample and assess
whether there are differences between immigrant women and non-immigrant Latina women on
these measures; b) quantify whether there is a correlation between ACTH, cortisol, and PPD
and whether there are differences between immigrant and non-immigrant Latina women; and c)
assess the feasibility of enrolling Latinas into a laboratory-based study that includes the
collection of venous blood for measurement of oxytocin, ACTH, and cortisol. Sixty prenatal
(34 to 37 weeks) Latinas (30 immigrants and 30 U.S.-born) who are between the ages of 18 and
45 will be enrolled. Women with a singleton pregnancy who are Latina, who intend to
breastfeed for more than 2 months, who have or do not have a history of depression, and who
are willing to be followed for 8 weeks after delivery will be enrolled in the study. Latinas
who report maternal or infant disorder that may interfere with breastfeeding; those who
endorse substance use, and/or who have or have had a psychiatric disorder (e.g., psychosis
or serious personality disorders) other than depression or anxiety will be excluded to
minimize risk and confounds with the outcomes of interest.
stress, trauma history, PPD, and lactation failure in the full 60-subject sample and assess
whether there are differences between immigrant women and non-immigrant Latina women on
these measures; b) quantify whether there is a correlation between ACTH, cortisol, and PPD
and whether there are differences between immigrant and non-immigrant Latina women; and c)
assess the feasibility of enrolling Latinas into a laboratory-based study that includes the
collection of venous blood for measurement of oxytocin, ACTH, and cortisol. Sixty prenatal
(34 to 37 weeks) Latinas (30 immigrants and 30 U.S.-born) who are between the ages of 18 and
45 will be enrolled. Women with a singleton pregnancy who are Latina, who intend to
breastfeed for more than 2 months, who have or do not have a history of depression, and who
are willing to be followed for 8 weeks after delivery will be enrolled in the study. Latinas
who report maternal or infant disorder that may interfere with breastfeeding; those who
endorse substance use, and/or who have or have had a psychiatric disorder (e.g., psychosis
or serious personality disorders) other than depression or anxiety will be excluded to
minimize risk and confounds with the outcomes of interest.
Study Objective: The purpose of the funded study is to determine a) examine associations
among OT levels, stress, trauma history, PPD, and lactation failure in the full 60-subject
sample and assess whether there are differences between immigrant women and non-immigrant
Latina women on these measures; b) quantify whether there is a correlation between ACTH,
cortisol, and PPD and whether there are differences between immigrant and non-immigrant
Latina women; and c) assess the feasibility of enrolling Latinas into a laboratory-based
study that includes the collection of venous blood for measurement of oxytocin, ACTH, and
cortisol.
Research Aims: 1) To examine associations among OT levels, stress, trauma history, PPD, and
lactation failure in the full 60-subject sample and assess whether there are differences
between immigrant women and non-immigrant Latina women on these measures; 2) To quantify
whether there is a correlation between ACTH, cortisol, and PPD and whether there are
differences between immigrant and non-immigrant Latina women; 3) To assess the feasibility
of enrolling Latinas into a laboratory-based study that includes the collection of venous
blood for measurement of oxytocin, ACTH, and cortisol; and 4) Assess the performance of the
Spanish language protocol and measures to identify barriers to implementation and address
needed modifications prior to large-scale implementation.
Subjects: Sixty prenatal (34 to 37 weeks) Latinas (30 immigrants and 30 U.S.-born) who are
between the ages of 18 and 45 will be enrolled. Women with a singleton pregnancy who are
Latina, who intend to breastfeed for more than 2 months, who have or do not have a history
of depression, and who are willing to be followed for 8 weeks after delivery will be
enrolled in the study. Latinas who report maternal or infant disorder that may interfere
with breastfeeding; those who endorse substance use, and/or who have or have had a
psychiatric disorder (e.g., psychosis or serious personality disorders) other than
depression or anxiety will be excluded to minimize risk and confounds with the outcomes of
interest.
Methods: There will be four study-time points: prenatal visit, 4- and 12-weeks postpartum
phone interviews, and one laboratory visit at 8-weeks postpartum. Participants will be
compensating after each interview.
Prenatal Visit: We will collect demographic information; assess depression and anxiety
status, as well as breastfeeding intention. During the prenatal visit we will also inquire
about acculturation and everyday stressors. English and Spanish validated measures will be
used.
Postpartum Phone Interviews: We will inquire about breastfeeding practices and self-efficacy
using the Breastfeeding Self-Efficacy-Short Form as well as depression status using the
EPDS.
Laboratory Visit: At 8 weeks postpartum, biomarkers will be collected via blood draws during
breastfeeding and the cold pressor stress test. Oxytocin will be collected during
breastfeeding and adrenocorticotropic hormone (ACTH) and cortisol will be collected after a
recovery period and during the cold pressor stress test. Childhood and Border-Crossing
Trauma will be collected following the laboratory procedures.
What will be gained: This study will enable us to begin to understand Latinas (immigrant and
U.S.-born) neuroendocrine responses to high levels of stress, which will enable us to and
determine associations between stress and trauma the development of postpartum depression.
This study will also enable us to identify risk factors for postpartum depression among
immigrant and U.S.-born Latinas.
among OT levels, stress, trauma history, PPD, and lactation failure in the full 60-subject
sample and assess whether there are differences between immigrant women and non-immigrant
Latina women on these measures; b) quantify whether there is a correlation between ACTH,
cortisol, and PPD and whether there are differences between immigrant and non-immigrant
Latina women; and c) assess the feasibility of enrolling Latinas into a laboratory-based
study that includes the collection of venous blood for measurement of oxytocin, ACTH, and
cortisol.
Research Aims: 1) To examine associations among OT levels, stress, trauma history, PPD, and
lactation failure in the full 60-subject sample and assess whether there are differences
between immigrant women and non-immigrant Latina women on these measures; 2) To quantify
whether there is a correlation between ACTH, cortisol, and PPD and whether there are
differences between immigrant and non-immigrant Latina women; 3) To assess the feasibility
of enrolling Latinas into a laboratory-based study that includes the collection of venous
blood for measurement of oxytocin, ACTH, and cortisol; and 4) Assess the performance of the
Spanish language protocol and measures to identify barriers to implementation and address
needed modifications prior to large-scale implementation.
Subjects: Sixty prenatal (34 to 37 weeks) Latinas (30 immigrants and 30 U.S.-born) who are
between the ages of 18 and 45 will be enrolled. Women with a singleton pregnancy who are
Latina, who intend to breastfeed for more than 2 months, who have or do not have a history
of depression, and who are willing to be followed for 8 weeks after delivery will be
enrolled in the study. Latinas who report maternal or infant disorder that may interfere
with breastfeeding; those who endorse substance use, and/or who have or have had a
psychiatric disorder (e.g., psychosis or serious personality disorders) other than
depression or anxiety will be excluded to minimize risk and confounds with the outcomes of
interest.
Methods: There will be four study-time points: prenatal visit, 4- and 12-weeks postpartum
phone interviews, and one laboratory visit at 8-weeks postpartum. Participants will be
compensating after each interview.
Prenatal Visit: We will collect demographic information; assess depression and anxiety
status, as well as breastfeeding intention. During the prenatal visit we will also inquire
about acculturation and everyday stressors. English and Spanish validated measures will be
used.
Postpartum Phone Interviews: We will inquire about breastfeeding practices and self-efficacy
using the Breastfeeding Self-Efficacy-Short Form as well as depression status using the
EPDS.
Laboratory Visit: At 8 weeks postpartum, biomarkers will be collected via blood draws during
breastfeeding and the cold pressor stress test. Oxytocin will be collected during
breastfeeding and adrenocorticotropic hormone (ACTH) and cortisol will be collected after a
recovery period and during the cold pressor stress test. Childhood and Border-Crossing
Trauma will be collected following the laboratory procedures.
What will be gained: This study will enable us to begin to understand Latinas (immigrant and
U.S.-born) neuroendocrine responses to high levels of stress, which will enable us to and
determine associations between stress and trauma the development of postpartum depression.
This study will also enable us to identify risk factors for postpartum depression among
immigrant and U.S.-born Latinas.
Inclusion Criteria:
- Prenatal Latina/Hispanic women 34 to 37 weeks
- Latina/Hispanic women 18 and 45 years of age
- Latina/Hispanic women with a singleton pregnancy
- Latina/Hispanic women who intend to breastfeed for more than 2 months
- Latina/Hispanic women who are willing to be followed for 16 weeks
Exclusion Criteria:
- Latina/Hispanic women who report maternal or infant disorder that may interfere with
breastfeeding
- Latina/Hispanic women who endorse substance use (alcohol and/or elicit drugs)
- Latina/Hispanic women who have or have had a psychiatric disorder (e.g., psychosis or
serious personality disorders) other than depression or anxiety
We found this trial at
1
site
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
Click here to add this to my saved trials
