Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Prenatal Depression and Failure to Breastfeed

16 ottobre 2014 aggiornato da: Pamela McCool, Oklahoma State University Center for Health Sciences

Prospective Study of Maternal Prenatal Depression as a Risk Factor for Failure to Breastfeed

The purpose of this prospective cohort study is to search for a relationship between maternal depression in the third trimester, as indicated by a score of > 12 on the EPDS, and a choice not to breastfeed at all, defined as no breastfeeding after dismissal from the hospital. The investigators hypothesize that women who screen positive for prenatal depression will be significantly less likely to breastfeed their babies after discharge from the hospital following childbirth.

Panoramica dello studio

Descrizione dettagliata

Introduction

Postpartum depression (PPD) is a form of major depressive disorder (MDD) and affects about 15% of mothers following birth (1). This condition is a serious medical matter, not only because of the suffering it causes the women, but because it can negatively affect the infant emotionally, socially, and even cognitively, sometimes far beyond the time of the depression (2). Many physicians now routinely screen for PPD at the traditional 4-6 week postpartum visit, and such screening has been the policy at OSU clinics for the past decade. However, Kim et al (2008) recently reported that testing pregnant women at 24-28 weeks gestation for depression resulted in a risk status that was identical with risk status after delivery for 90% of patients studied (3). The author concluded that prenatal screening for possible later PPD seemed clinically useful.

Various studies have investigated a possible relationship between PPD and failure to breastfeed, with mixed results. Misri et al (1997) reported that 83% of their subjects with PPD experienced onset after discontinuing breastfeeding (4). Henderson et al (2003) reported that a study of 1,745 Australian women revealed that subjects with PPD were more likely to stop breastfeeding than non-depressed ones (5). In addition, they found that the women tended to wean after onset of PPD (5). However, McKee et al (2004) found no association between PPD and beginning or duration of breastfeeding (6). Further, Hatton et al (2005) found that although women with more depressive symptoms were less likely to breastfeed at 6 weeks postpartum than their counterparts without symptoms, this difference could not be found at 12 weeks postpartum (7).

Here at OSU, Dr. Sarah McCoy published two studies on breastfeeding and PPD in 2006 and 2008, both of which were retrospective reviews of records (8, 9). The first one was a more selective and smaller sample than the second, because at the time the data were collected, PPD screening had not quite become universal. In that first study of 209 subjects, a significant relationship was found between breastfeeding and scores above 12 on the Edinburgh Postnatal Depression Scale (EPDS), which indicated PPD (8). However, the second similarly-designed study of 588 subjects, which was a more representative sample of the clinic population, failed to confirm those results (9).

To date, little if any studies have been published that deal directly with the topic of prenatal depression and its relationship to whether a woman chooses to breastfeed after giving birth. However, McCarter-Spaulding and Horowitz (2007) recently recommended prenatal screening for PPD in anticipation of potential roadblocks to breastfeeding (10). If it could be shown that women with prenatal depressive symptoms are less likely to choose breastfeeding, perhaps early intervention could increase the number of infants that are breastfed, which is an important public-health goal (11).

Purpose The purpose of this prospective cohort study is to search for a relationship between maternal depression in the third trimester, as indicated by a score of > 12 on the EPDS, and a choice not to breastfeed at all, defined as no breastfeeding after dismissal from the hospital.

Methods The investigators plan to collect data from women that are receiving prenatal care at the OSU Houston Parke clinic. Upon obtaining informed consent at a prenatal appointment between 34 weeks + 0 days gestation and 37 weeks + 6 days, (should consent be deemed necessary), the investigators will ask the subjects to fill out the same EPDS screen that OSU obstetrics patients already typically fill out at the four-week postpartum appointment. Filling out that scale at a prenatal appointment is the only activity that the test subjects will be asked to do that is not already a standard part of their obstetrics' treatment. In addition, the investigators will note these women's EPDS score at the four-week postpartum visit and whether or not they choose to breastfeed, as well as the other information listed under "Data Collection", most of which are already routinely recorded in the chart.

Early Termination Criteria Patient will also be terminated if they do not follow up at their postpartum visit.

Drugs and Dosages No drugs are used in this project. Devices The only device used in this study is the EPDS. Surgical Procedures This study does not include any surgical procedures. Data Collection

Information recorded for the study will include:

  1. Gestational age at prenatal EPDS screen
  2. Prenatal EPDS score
  3. Use of any antidepressants at the time of the prenatal screening
  4. Use of any antidepressants after the prenatal screening
  5. Age of patient
  6. Whether infant was stillborn yes/no
  7. Whether infant had birth defects yes/no
  8. Whether infant had illness that prevented breastfeeding
  9. Whether infant breastfed at all after leaving the hospital
  10. Whether infant was still breastfeeding at the four-week postnatal appointment

Confidentiality Data will be de-identified after the four-week postpartum visit by conversion to numbers. It will be recorded on an Excel spreadsheet.

Tipo di studio

Osservativo

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 52 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Femmina

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Women receiving prenatal care at the OSU Houston Parke obstetrics clinic in Tulsa, Oklahoma, who are in their third trimester between 34 and 38 weeks gestation

Descrizione

Inclusion Criteria:

1. Pregnant female in third trimester obtaining prenatal care through OSU Houston Parke obstetrics clinic 2. All questions of both EPDS assessments completed, one at 34 + 0 days-37 + 6 days weeks gestation and one at the standard four-week postnatal examination 3. Breastfeeding status noted on chart at four-week postpartum examination, yes/no, with yes defined as any activity, exclusive or partial, after dismissal from the hospital

-

Exclusion Criteria:

1. Use of anti-depressive medication after initial prenatal EPDS administration 2. Mothers of stillborn infants, infants with an illness that prevented breastfeeding, or of infants with birth defects 3. Incomplete EPDS questionnaire, either prenatal or postnatal

-

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Prenatally depressed
Women who tested positive for prenatal depression with a score of > 12 on the Edinburgh Postnatal Depression Scale
Not Prenatally Depressed
Women who tested not depressed on the prenatal depression scale with a score < 13

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
EPDS score
Lasso di tempo: late third trimester - four weeks postpartum
Numerical value on maternal depression screening test
late third trimester - four weeks postpartum

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Pamela J McCool, DO, Oklahoma State University Center for Health Sciences

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2011

Completamento primario (Anticipato)

1 luglio 2012

Completamento dello studio (Anticipato)

1 luglio 2012

Date di iscrizione allo studio

Primo inviato

1 dicembre 2010

Primo inviato che soddisfa i criteri di controllo qualità

2 dicembre 2010

Primo Inserito (Stima)

3 dicembre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

20 ottobre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 ottobre 2014

Ultimo verificato

1 ottobre 2014

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2010-024

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi