NCT01252602

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
12 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

December 1, 2010

Last Update Submit

October 16, 2014

Conditions

Keywords

breastfeeding, EPDS, prenatal depression

Outcome Measures

Primary Outcomes (1)

  • EPDS score

    Numerical value on maternal depression screening test

    late third trimester - four weeks postpartum

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • \. 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Pamela J McCool, DO

    Oklahoma State University Center for Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
OBGYN

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 3, 2010

Study Start

December 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 20, 2014

Record last verified: 2014-10