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NCT00782912 Clinical Trial

Postpartum Anemia and Postpartum Depression

Postpartum Depression Clinical Trial

— PPADS  

Official title:
Is Postpartum Anemia an Independent Risk Factor for Development of Postpartum Depression?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00782912
Other study ID # 08-155
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2008
Est. completion date October 2014

Study information
Verified date February 2019
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 103
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of postpartum depression 0-6 weeks postpartum
Secondary Mean Edinburgh Postnatal Depression Scale results 0-6 weeks postpartum
Secondary Functional status 0-6 weeks postpartum
Secondary Lactation success 0-6 weeks postpartum
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