Postpartum DepressionNCT01658098
Prevalence of Postpartum Depression in Hospital Jose E. Gonzalez
An observational study of Postpartum Depression, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
This research will use the Edinburgh Scale Of Post partum depression to evaluate patients during their 4th to 6th after delivery, and the investigators will compare the results with those found in other countries with population with similar characteristics as ours Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- edinburgh postpartum depression scale questionary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 348 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2012to Feb 2013
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: 348 patients on their 4th-6th week after delivery
Who may be able to join
- patients on their 4th -6th week after delivery, who gave birth in our institution
Who cannot join
- patients with previous diagnosis of psychiatric pathology
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr Jose E. Gonzalez
Monterrey, Nuevo León, 64460
Edgar Tamez, resident, 01528183530442, julc316@hotmail.com
sara Peña, resident, 01528181231928, trysha_16@hotmail.com
About this study
Official title: Prevalence of Postpartum Depression in the Jose E. Gonzalez Hospital, Using the Edinburgh Postpartum Depression Scale
This research will use the Edinburgh Scale Of Post partum depression to evaluate patients during their 4th to 6th after delivery, and the investigators will compare the results with those found in other countries with population with similar characteristics as ours
- Conditions
- Postpartum Depression
- Being tested
- edinburgh postpartum depression scale questionary
- Keywords
- postpartum, depression, edinburgh postpartum depression scale, mexican population
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edinburgh postpartum depression scale questionaryBehavioural
the investigators will apply the qusetionary one time only in the period of time described previously
| Study group | Role | What they receive |
|---|---|---|
| 4-6 weeks after delivery | all patients on their 4th-6th weeks after delivery Receives: Behavioral: edinburgh postpartum depression scale questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of postpartum depression
Measured: 2 months
Secondary outcomes (4)
sociodemographic characteristics
age
Measured: 2 months
sociodemographic characteristics
level of education
Measured: 2 month
obstetrical background
number of pregnancies
Measured: 2 month
medical background
comorbid ities
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Prospective
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Edgar Alejandro Tamez Cristerna, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Emilio Treviño, specialist, Study director, Consejo mexicano de ginecologia y obstetricia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658098
- Sponsor's protocol ID
- etamez
- Status last verified
- Jul 2012
- First submitted
- 30 Jul 2012
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dennis CL. Can we identify mothers at risk for postpartum depression in the immediate postpartum period using the Edinburgh Postnatal Depression Scale? J Affect Disord. 2004 Feb;78(2):163-9. doi: 10.1016/s0165-0327(02)00299-9.
PubMed 14706728Yang SN, Shen LJ, Ping T, Wang YC, Chien CW. The delivery mode and seasonal variation are associated with the development of postpartum depression. J Affect Disord. 2011 Jul;132(1-2):158-64. doi: 10.1016/j.jad.2011.02.009. Epub 2011 Mar 4.
PubMed 21377210Petrosyan D, Armenian HK, Arzoumanian K. Interaction of maternal age and mode of delivery in the development of postpartum depression in Yerevan, Armenia. J Affect Disord. 2011 Dec;135(1-3):77-81. doi: 10.1016/j.jad.2011.06.061. Epub 2011 Aug 10.
PubMed 21835474Xie RH, He G, Liu A, Bradwejn J, Walker M, Wen SW. Fetal gender and postpartum depression in a cohort of Chinese women. Soc Sci Med. 2007 Aug;65(4):680-4. doi: 10.1016/j.socscimed.2007.04.003. Epub 2007 May 15.
PubMed 17507127Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033.
PubMed 19318144Jadresic E, Nguyen DN, Halbreich U. What does Chilean research tell us about postpartum depression (PPD)? J Affect Disord. 2007 Sep;102(1-3):237-43. doi: 10.1016/j.jad.2006.09.032. Epub 2006 Nov 27.
PubMed 17125843Affonso DD, De AK, Horowitz JA, Mayberry LJ. An international study exploring levels of postpartum depressive symptomatology. J Psychosom Res. 2000 Sep;49(3):207-16. doi: 10.1016/s0022-3999(00)00176-8.
PubMed 11110992Sylven SM, Papadopoulos FC, Olovsson M, Ekselius L, Poromaa IS, Skalkidou A. Seasonality patterns in postpartum depression. Am J Obstet Gynecol. 2011 May;204(5):413.e1-6. doi: 10.1016/j.ajog.2011.01.022. Epub 2011 Mar 24.
PubMed 21439544Halbreich U, Karkun S. Cross-cultural and social diversity of prevalence of postpartum depression and depressive symptoms. J Affect Disord. 2006 Apr;91(2-3):97-111. doi: 10.1016/j.jad.2005.12.051. Epub 2006 Feb 7.
PubMed 16466664Miyake Y, Tanaka K, Sasaki S, Hirota Y. Employment, income, and education and risk of postpartum depression: the Osaka Maternal and Child Health Study. J Affect Disord. 2011 Apr;130(1-2):133-7. doi: 10.1016/j.jad.2010.10.024. Epub 2010 Nov 4.
PubMed 21055825Latorre-Latorre JF, Contreras-Pezzotti LM, Herran-Falla OF. [Postnatal depression in a Colombian city. Risk factors]. Aten Primaria. 2006 Apr 15;37(6):332-8. doi: 10.1157/13086714. Spanish.
PubMed 16733006Delatte R, Cao H, Meltzer-Brody S, Menard MK. Universal screening for postpartum depression: an inquiry into provider attitudes and practice. Am J Obstet Gynecol. 2009 May;200(5):e63-4. doi: 10.1016/j.ajog.2008.12.022. Epub 2009 Mar 14.
PubMed 19285644Hewitt C, Gilbody S, Brealey S, Paulden M, Palmer S, Mann R, Green J, Morrell J, Barkham M, Light K, Richards D. Methods to identify postnatal depression in primary care: an integrated evidence synthesis and value of information analysis. Health Technol Assess. 2009 Jul;13(36):1-145, 147-230. doi: 10.3310/hta13360.
PubMed 19624978Jadresic E, Araya R, Jara C. Validation of the Edinburgh Postnatal Depression Scale (EPDS) in Chilean postpartum women. J Psychosom Obstet Gynaecol. 1995 Dec;16(4):187-91. doi: 10.3109/01674829509024468.
PubMed 8748993Castanon S C, Pinto L J. [Use of the Edinburgh Postnatal Depression Scale to detect postpartum depression]. Rev Med Chil. 2008 Jul;136(7):851-8. Epub 2008 Sep 4. Spanish.
PubMed 18949160
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Postpartum Depression in the Jose E. Gonzalez Hospital, Using the Edinburgh Postpartum Depression Scale
- ClinicalTrials.gov ID
- NCT01658098
- Acronym / sponsor ID
- etamez
- Conditions
- Postpartum Depression
- Keywords
- postpartum, depression, edinburgh postpartum depression scale, mexican population
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 6 Aug 2012 (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.
This research will use the Edinburgh Scale Of Post partum depression to evaluate patients during their 4th to 6th after delivery, and the investigators will compare the results with those found in other countries with population with similar characteristics as ours
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4-6 weeks after delivery | – | Behavioral: edinburgh postpartum depression scale questionaryall patients on their 4th-6th weeks after delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 348 patients on their 4th-6th week after delivery
Key inclusion criteria (1 listed)
- patients on their 4th -6th week after delivery, who gave birth in our institution
Key exclusion criteria (1 listed)
- patients with previous diagnosis of psychiatric pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| edinburgh postpartum depression scale questionarythe investigators will apply the qusetionary one time only in the period of time described previously | Behavioural | 4-6 weeks after delivery |
Primary outcome
presence of postpartum depression
Time frame: 2 months
4 secondary outcomes
sociodemographic characteristics
Time frame: 2 months
sociodemographic characteristics
Time frame: 2 month
obstetrical background
Time frame: 2 month
medical background
Time frame: 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Background: PubMed 14706728Dennis CL. Can we identify mothers at risk for postpartum depression in the immediate postpartum period using the Edinburgh Postnatal Depression Scale? J Affect Disord. 2004 Feb;78(2):163-9. doi: 10.1016/s0165-0327(02)00299-9.
- Background: PubMed 21377210Yang SN, Shen LJ, Ping T, Wang YC, Chien CW. The delivery mode and seasonal variation are associated with the development of postpartum depression. J Affect Disord. 2011 Jul;132(1-2):158-64. doi: 10.1016/j.jad.2011.02.009. Epub 2011 Mar 4.
- Background: PubMed 21835474Petrosyan D, Armenian HK, Arzoumanian K. Interaction of maternal age and mode of delivery in the development of postpartum depression in Yerevan, Armenia. J Affect Disord. 2011 Dec;135(1-3):77-81. doi: 10.1016/j.jad.2011.06.061. Epub 2011 Aug 10.
- Background: PubMed 17507127Xie RH, He G, Liu A, Bradwejn J, Walker M, Wen SW. Fetal gender and postpartum depression in a cohort of Chinese women. Soc Sci Med. 2007 Aug;65(4):680-4. doi: 10.1016/j.socscimed.2007.04.003. Epub 2007 May 15.
- Background: PubMed 19318144Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033.
- Background: PubMed 17125843Jadresic E, Nguyen DN, Halbreich U. What does Chilean research tell us about postpartum depression (PPD)? J Affect Disord. 2007 Sep;102(1-3):237-43. doi: 10.1016/j.jad.2006.09.032. Epub 2006 Nov 27.
- Background: PubMed 11110992Affonso DD, De AK, Horowitz JA, Mayberry LJ. An international study exploring levels of postpartum depressive symptomatology. J Psychosom Res. 2000 Sep;49(3):207-16. doi: 10.1016/s0022-3999(00)00176-8.
- Background: PubMed 21439544Sylven SM, Papadopoulos FC, Olovsson M, Ekselius L, Poromaa IS, Skalkidou A. Seasonality patterns in postpartum depression. Am J Obstet Gynecol. 2011 May;204(5):413.e1-6. doi: 10.1016/j.ajog.2011.01.022. Epub 2011 Mar 24.
- Background: PubMed 16466664Halbreich U, Karkun S. Cross-cultural and social diversity of prevalence of postpartum depression and depressive symptoms. J Affect Disord. 2006 Apr;91(2-3):97-111. doi: 10.1016/j.jad.2005.12.051. Epub 2006 Feb 7.
- Background: PubMed 21055825Miyake Y, Tanaka K, Sasaki S, Hirota Y. Employment, income, and education and risk of postpartum depression: the Osaka Maternal and Child Health Study. J Affect Disord. 2011 Apr;130(1-2):133-7. doi: 10.1016/j.jad.2010.10.024. Epub 2010 Nov 4.
- Background: PubMed 16733006Latorre-Latorre JF, Contreras-Pezzotti LM, Herran-Falla OF. [Postnatal depression in a Colombian city. Risk factors]. Aten Primaria. 2006 Apr 15;37(6):332-8. doi: 10.1157/13086714. Spanish.
- Background: PubMed 19285644Delatte R, Cao H, Meltzer-Brody S, Menard MK. Universal screening for postpartum depression: an inquiry into provider attitudes and practice. Am J Obstet Gynecol. 2009 May;200(5):e63-4. doi: 10.1016/j.ajog.2008.12.022. Epub 2009 Mar 14.
Related trials for Postpartum Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
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.
Emilio Treviño, specialist study director
Consejo mexicano de ginecologia y obstetricia
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 Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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: status not confirmed, as of the sponsor's last update on 6 Aug 2012. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of postpartum depression (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01658098, which also lists 16 linked publications.
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 6 Aug 2012.