- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00782912
Postpartum Anemia and Postpartum Depression (PPADS)
February 20, 2019 updated by: Unity Health Toronto
Is Postpartum Anemia an Independent Risk Factor for Development of Postpartum Depression?
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
103
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
-
Toronto, Ontario, Canada, M5B1W8
- St. Michael's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women after term elective cesarean section
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of postpartum depression
Time Frame: 0-6 weeks postpartum
|
0-6 weeks postpartum
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Edinburgh Postnatal Depression Scale results
Time Frame: 0-6 weeks postpartum
|
0-6 weeks postpartum
|
Functional status
Time Frame: 0-6 weeks postpartum
|
0-6 weeks postpartum
|
Lactation success
Time Frame: 0-6 weeks postpartum
|
0-6 weeks postpartum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
October 30, 2008
First Submitted That Met QC Criteria
October 30, 2008
First Posted (Estimate)
October 31, 2008
Study Record Updates
Last Update Posted (Actual)
February 22, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-155
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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