Postpartum DepressionPPADSNCT00782912
Postpartum Anemia and Postpartum Depression
An observational study of Postpartum Depression, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women after term elective cesarean section
Who may be able to join
- Women after term elective cesarean section
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Postpartum Depression
- Keywords
- postpartum anemia, postpartum depression
- Medical subject headings
- Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postpartum depression
Measured: 0-6 weeks postpartum
Secondary outcomes (3)
Mean Edinburgh Postnatal Depression Scale results
Measured: 0-6 weeks postpartum
Functional status
Measured: 0-6 weeks postpartum
Lactation success
Measured: 0-6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Berger, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782912
- Sponsor's protocol ID
- 08-155
- Acronym
- PPADS
- Status last verified
- Feb 2019
- First submitted
- 30 Oct 2008
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Postpartum Anemia an Independent Risk Factor for Development of Postpartum Depression?
- ClinicalTrials.gov ID
- NCT00782912
- Acronym / sponsor ID
- PPADS / 08-155
- Conditions
- Postpartum Depression
- Keywords
- postpartum anemia, postpartum depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women after term elective cesarean section
Key inclusion criteria (1 listed)
- Women after term elective cesarean section
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postpartum depression
Time frame: 0-6 weeks postpartum
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Berger, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postpartum depression (time frame: 0-6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.