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Postpartum Anemia and Postpartum Depression (PPADS)
This study has been completed.
Sponsor:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00782912
First received: October 30, 2008
Last updated: April 20, 2015
Last verified: April 2015
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Purpose
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 |
|---|
| Postpartum Depression |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Is Postpartum Anemia an Independent Risk Factor for Development of Postpartum Depression? |
Resource links provided by NLM:
Further study details as provided by St. Michael's Hospital, Toronto:
Primary Outcome Measures:
- Incidence of postpartum depression [ Time Frame: 0-6 weeks postpartum ]
Secondary Outcome Measures:
- Mean Edinburgh Postnatal Depression Scale results [ Time Frame: 0-6 weeks postpartum ]
- Functional status [ Time Frame: 0-6 weeks postpartum ]
- Lactation success [ Time Frame: 0-6 weeks postpartum ]
Biospecimen Retention: Samples With DNA
Blood samples
| Enrollment: | 103 |
| Study Start Date: | November 2008 |
| Study Completion Date: | October 2014 |
| Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00782912
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | St. Michael's Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT00782912 History of Changes |
| Other Study ID Numbers: |
REB 08-155 |
| Study First Received: | October 30, 2008 |
| Last Updated: | April 20, 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 |
ClinicalTrials.gov processed this record on August 23, 2017