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WithdrawnNCT01252602Updated Oct 20, 2014

Prenatal Depression and Failure to Breastfeed

An observational study in Breastfeeding After Discharge From Hospital Following Childbirth, Yes/no and Depression Scale Score, sponsored by Oklahoma State University Center for Health Sciences. Withdrawn. Open to female participants aged 18 Years to 52 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-20.

Sponsored by Oklahoma State University Center for Health Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 52 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Breastfeeding After Discharge From Hospital Following Childbirth, Yes/no
  • Depression Scale Score

Keywords

  • breastfeeding, EPDS, prenatal depression
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

Browse Depression studies →

Lead sponsor

Oklahoma State University Center for Health Sciences is the lead sponsor of 34 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 52 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

-

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

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. EPDS score

    Numerical value on maternal depression screening test

    Time frame: late third trimester - four weeks postpartum

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Hatton DC, Harrison-Hohner J, Coste S, Dorato V, Curet LB, McCarron DA. Symptoms of postpartum depression and breastfeeding. J Hum Lact. 2005 Nov;21(4):444-9; quiz 450-4. doi: 10.1177/0890334405280947. PubMed 16280561 ↗
  • Kim JJ, Gordon TE, La Porte LM, Adams M, Kuendig JM, Silver RK. The utility of maternal depression screening in the third trimester. Am J Obstet Gynecol. 2008 Nov;199(5):509.e1-5. doi: 10.1016/j.ajog.2008.04.018. Epub 2008 Jun 4. PubMed 18533122 ↗
  • Henderson JJ, Evans SF, Straton JA, Priest SR, Hagan R. Impact of postnatal depression on breastfeeding duration. Birth. 2003 Sep;30(3):175-80. doi: 10.1046/j.1523-536x.2003.00242.x. Erratum In: Birth. 2004 Mar;31(1):76. PubMed 12911800 ↗
  • McCoy SJ, Beal JM, Shipman SB, Payton ME, Watson GH. Risk factors for postpartum depression: a retrospective investigation at 4-weeks postnatal and a review of the literature. J Am Osteopath Assoc. 2006 Apr;106(4):193-8. Erratum In: J Am Osteopath Assoc. 2006 Dec;106(12):687. J Am Osteopath Assoc. 2008 Apr;108(4):217. PubMed 16627773 ↗
  • McCoy SJ, Beal JM, Saunders B, Hill EN, Payton ME, Watson GH. Risk factors for postpartum depression: a retrospective investigation. J Reprod Med. 2008 Mar;53(3):166-70. PubMed 18441719 ↗
  • McCarter-Spaulding D, Horowitz JA. How does postpartum depression affect breastfeeding? MCN Am J Matern Child Nurs. 2007 Jan-Feb;32(1):10-7. doi: 10.1097/00005721-200701000-00004. PubMed 17308452 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01252602
Lead sponsor
Oklahoma State University Center for Health Sciences
Responsible party
Pamela McCool (OBGYN, Oklahoma State University Center for Health Sciences) — Principal investigator
First posted
Dec 3, 2010
Start date
Dec 2011
Primary completion
Jul 2012 (estimated)
Completion
Jul 2012 (estimated)
Last update
Oct 20, 2014

Study contacts

Pamela J McCool, DO
principal investigator · Oklahoma State University Center for Health Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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