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Postpartum Anemia and Postpartum Depression (PPADS)

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ClinicalTrials.gov Identifier: NCT00782912
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Study Description
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Brief Summary:
Postpartum anemia (PPA) and Postpartum depression (PPD) are common afflictions affecting women after childbirth. Both disorders have a significant impact on women's health and functional status. Despite common symptoms and characteristics, a link between these entities has not been adequately studied. The objective of this study is to determine whether postpartum anemia is an independent risk factor for the development of postpartum depression. This prospective cohort study will include all women delivered by elective term cesarean delivery. Hemoglobin and iron levels will be measured, standardized questionnaires for assessment of PPD, functional status and lactation will be administered before discharge and at 3 & 6 weeks post partum. Hemoglobin levels at each time point will be analyzed for correlation with depressive symptoms, functional status and lactation success.

Condition or disease
Postpartum Depression

Study Design
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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Is Postpartum Anemia an Independent Risk Factor for Development of Postpartum Depression?
Study Start Date : November 2008
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of postpartum depression [ Time Frame: 0-6 weeks postpartum ]

Secondary Outcome Measures :
  1. Mean Edinburgh Postnatal Depression Scale results [ Time Frame: 0-6 weeks postpartum ]
  2. Functional status [ Time Frame: 0-6 weeks postpartum ]
  3. Lactation success [ Time Frame: 0-6 weeks postpartum ]

Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women after term elective cesarean section
Criteria

Inclusion Criteria:

  • Women after term elective cesarean section

Exclusion Criteria:

  • age < 16 years, preterm (< 37 weeks) delivery, multiple gestation, symptomatic anemia necessitating blood transfusion, significant fetal anomalies or infant not discharged with mother for other reason, preexisting severe chronic maternal illness, preexisting maternal depression and/or current use of antidepressants, other psychiatric illness (e.g. bipolar disease, schizophrenia) or preexisting hemoglobinopathy
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782912


Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Howard Berger, MD St. Michael's Hospital, Toronto
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00782912     History of Changes
Other Study ID Numbers: REB 08-155
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by St. Michael's Hospital, Toronto:
postpartum anemia, postpartum depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anemia
Depression, Postpartum
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Hematologic Diseases
Puerperal Disorders
Pregnancy Complications