Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size
Trial record 3 of 210 for:    postpartum depression
Previous Study | Return to List | Next Study

Postpartum Anemia and Postpartum Depression (PPA PPD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00782912
First received: October 30, 2008
Last updated: May 23, 2014
Last verified: May 2014
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Incidence of postpartum depression [ Time Frame: 0-6 weeks postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Edinburgh Postnatal Depression Scale results [ Time Frame: 0-6 weeks postpartum ] [ Designated as safety issue: No ]
  • Functional status [ Time Frame: 0-6 weeks postpartum ] [ Designated as safety issue: No ]
  • Lactation success [ Time Frame: 0-6 weeks postpartum ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples
Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility
Genders 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
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: 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

No publications provided

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: May 23, 2014
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on March 03, 2015