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

5 december 2014 bijgewerkt door: Sandraluz Lara-Cinisomo, PhD, University of North Carolina, Chapel Hill

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.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

34

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27516
        • University of North Carolina, Chapel Hill

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Latinas (foreign and U.S.-born)

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postpartum depression
Tijdsspanne: third trimester to 12 weeks postpartum
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Sandraluz Lara-Cinisomo, Ph.D., UNC Chapel Hill

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2013

Primaire voltooiing (Werkelijk)

1 september 2014

Studie voltooiing (Werkelijk)

1 september 2014

Studieregistratiedata

Eerst ingediend

24 juli 2013

Eerst ingediend dat voldeed aan de QC-criteria

29 juli 2013

Eerst geplaatst (Schatting)

31 juli 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

8 december 2014

Laatste update ingediend die voldeed aan QC-criteria

5 december 2014

Laatst geverifieerd

1 december 2014

Meer informatie

Termen gerelateerd aan deze studie

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