Study of Exposure to Stress, Postpartum Mood, Adverse Life Events, and Hormonal Function Among Latinas (SEPAH Latina)

NCT ID: NCT01912833

Last Updated: 2014-12-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Postpartum Depression

Keywords

postpartum depression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Sandraluz Lara-Cinisomo, PhD

Postdoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandraluz Lara-Cinisomo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

13-0788

Identifier Type: -

Identifier Source: org_study_id