Prenatal Depression and Failure to Breastfeed

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pamela McCool, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT01252602
First received: December 1, 2010
Last updated: October 16, 2014
Last verified: October 2014
  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. 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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Maternal Prenatal Depression as a Risk Factor for Failure to Breastfeed

Resource links provided by NLM:


Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • EPDS score [ Time Frame: late third trimester - four weeks postpartum ] [ Designated as safety issue: No ]
    Numerical value on maternal depression screening test


Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 52 Years
Genders Eligible for Study:   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

Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252602

Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Pamela J McCool, DO Oklahoma State University Center for Health Sciences
  More Information

Publications:
Responsible Party: Pamela McCool, OBGYN, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT01252602     History of Changes
Other Study ID Numbers: 2010-024
Study First Received: December 1, 2010
Last Updated: October 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
breastfeeding, EPDS, prenatal depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 20, 2014