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Prenatal Depression and Failure to Breastfeed

2014. október 16. frissítette: 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.

A tanulmány áttekintése

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Női

Mintavételi módszer

Valószínűségi minta

Tanulmányi populáció

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

Leírás

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

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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

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Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
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

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
EPDS score
Időkeret: late third trimester - four weeks postpartum
Numerical value on maternal depression screening test
late third trimester - four weeks postpartum

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Nyomozók

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

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2011. december 1.

Elsődleges befejezés (Várható)

2012. július 1.

A tanulmány befejezése (Várható)

2012. július 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2010. december 1.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2010. december 2.

Első közzététel (Becslés)

2010. december 3.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2014. október 20.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2014. október 16.

Utolsó ellenőrzés

2014. október 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Egyéb vizsgálati azonosító számok

  • 2010-024

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