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

NCT01912833 | Completed

• 1 other identifier: 13-0788
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Keywords

postpartum depression

Outcome Measures

Primary Outcomes (1)

• Postpartum depression

  Postpartum depression will be assessed using the Edinburgh Postpartum Depression Scale (EPDS), a 10-item questionnaire that helps to identify women who have postpartum depression.

  third trimester to 12 weeks postpartum

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Latinas (foreign and U.S.-born)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

oxytocin, cortisol, and adrenocorticotropic hormone (ACTH)

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sandraluz Lara-Cinisomo, Ph.D.

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 31, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

US (1)