Postpartum DepressionNCT03763435
The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression
An observational study of Postpartum Depression and Sleep Disorder, run by Bartin State Hospital at 1 site in Turkey (Türkiye).
Trial summary
It is recommended by the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice that all obstetricians screen each women for postpartum depression and anxiety with a validated instrument. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Depression, Sleep Disorder, Breast Feeding
- What is being tested?
- Antenatal pregnancy classes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2018to 15 Jul 2019
- 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: All women who gave birth in Bartin State Hospital (the only one hospital in the city) after October 2018. for three months.
Who may be able to join
- All women in the puerpera period (who gave consent)
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bartin State Hospital
Bartın
Murat Yassa, MD
Nahide YAZICI, Midwife
About this study
Official title: The Effects of Pregnancy Classes on Postpartum Depression and Contributing Factors to Postpartum Depression
It is recommended by the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice that all obstetricians screen each women for postpartum depression and anxiety with a validated instrument. Although much effort is made, the contributing factors still lack in the literature due to its multi-factorial nature and complexity.
In addition, the effects of prenatal education classes remain understudied. Therefore, this study aims to demonstrate the prevalence, characteristics and contributing factors of the postpartum depression. In addition, the change in prevalence and characteristics of the postpartum depression among women who had prenatal classes and not will also be assessed.
Read the detailed description
Specific and validated instruments will be performed to women in their 8th week of postpartum period.
Those instruments are:
Edinburgh Postpartum Depression Scale (EPDS) Female genital self-image scale (FGSIS) Insomnia Severity Index (ISI) Breast-feeding efficacy scale short form (BSES-SF) Beck Depression Scale
- Conditions
- Postpartum Depression, Sleep Disorder, Breast Feeding, Self Esteem
- Being tested
- Antenatal pregnancy classes
- Keywords
- postpartum depression, sleep disorder, genital self-image, breast-feeding, prevalence
- Medical subject headings
- Depression, Postpartum, Sleep Wake Disorders, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal pregnancy classesBehavioural
At least three comprehensive full-day educational program covering all the stages of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Antenatal Classes Received | Women who are involved into at least 3 comprehensive session of Antenatal pregnancy classes (educational) during the prenatal period. Receives: Behavioral: Antenatal pregnancy classes | |
| Without education | Groups are not randomized for not to give rise to ethical problems in order to maximize the community health care. Only women who are not involved into the educational classes due to their inaccessibility related to their own conditions or wishes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Depression
Postpartum Depression scores will be measured by Edinburgh Postpartum Scale (EDPS). The EDPS was developed to identify women who may have postpartum depression. Each answer is given a score of 0 to 3 . The maximum score is 30. The EPDS is a 10-item questionnaire. Women are asked to answer each question in terms of the past seven days. A score is calculated by adding the individual items as indicated A score of more than 10 suggests minor or major depression may be present.
Measured: Change between the 4th, 8th and 12th weeks of postpartum period
Secondary outcomes (4)
Genital self-image
Genital Self-image scores will be measured by Female Genital Self Image Scale (FGSIS). FGSIS measures the genital self-image of the participants.
The seven-item FGSIS assesses women's feelings and beliefs about their own genitals using a 4-point response scale (strongly agree, agree, disagree, strongly disagree).
Respondents'scores on each item were summed for a total sum score ranging from 7 to 28, with higher scores indicating more positive genital self-image.
Measured: At 4th, 8th and 12th week of postpartum period
sleep disorders
Sleep problems will be measured by Insomnia Severity Index (ISI). The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: At 4th, 8th and 12th week of postpartum period
breast-feeding
Breast-feeding will be assessed by the Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). It is a 14 item self-report instrument developed to measure a mother's perceived ability to breastfeed her infant. It has a five-point Likert scale for rating from 1 ("not at all confident") to 5 ("always confident"). Items ratings will be summed to produce a total score from 14 to 70, with higher scores indicating higher confidence. The means score points will be used as the cut-off point between high and low scorers.
Measured: At 4th, 8th and 12th week of postpartum period
socio-economic-demographical features
Social, economic and demographic features will be assessed by a structured non-validated data gathering form
Measured: At 4th postpartum week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start7 Dec 2018
- Primary completion15 Jun 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartin State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Murat Yassa, Bartin State Hospital
- Investigators
- Murat Yassa, MD, Principal investigator, Bartin State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763435
- Sponsor's protocol ID
- Bartin2018-3
- Status last verified
- Apr 2019
- First submitted
- 24 Nov 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lanes A, Kuk JL, Tamim H. Prevalence and characteristics of postpartum depression symptomatology among Canadian women: a cross-sectional study. BMC Public Health. 2011 May 11;11:302. doi: 10.1186/1471-2458-11-302.
PubMed 21569372
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pregnancy Classes on Postpartum Depression and Contributing Factors to Postpartum Depression
- ClinicalTrials.gov ID
- NCT03763435
- Acronym / sponsor ID
- Bartin2018-3
- Conditions
- Postpartum Depression, Sleep Disorder, Breast Feeding, Self Esteem
- Keywords
- postpartum depression, sleep disorder, genital self-image, breast-feeding, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Bartin State HospitalOther government
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 4 Dec 2018 (actual)
- 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.
It is recommended by the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice that all obstetricians screen each women for postpartum depression and anxiety with a validated instrument. Although much effort is made, the contributing factors still lack in the literature due to its multi-factorial nature and complexity.
In addition, the effects of prenatal education classes remain understudied. Therefore, this study aims to demonstrate the prevalence, characteristics and contributing factors of the postpartum depression. In addition, the change in prevalence and characteristics of the postpartum depression among women who had prenatal classes and not will also be assessed.
Detailed description
Specific and validated instruments will be performed to women in their 8th week of postpartum period.
Those instruments are:
Edinburgh Postpartum Depression Scale (EPDS) Female genital self-image scale (FGSIS) Insomnia Severity Index (ISI) Breast-feeding efficacy scale short form (BSES-SF) Beck Depression Scale
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antenatal Classes Received | – | Behavioral: Antenatal pregnancy classesWomen who are involved into at least 3 comprehensive session of Antenatal pregnancy classes (educational) during the prenatal period. |
| Without education | – | –Groups are not randomized for not to give rise to ethical problems in order to maximize the community health care. Only women who are not involved into the educational classes due to their inaccessibility related to their own conditions or wishes. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women who gave birth in Bartin State Hospital (the only one hospital in the city) after October 2018. for three months.
Key inclusion criteria (1 listed)
- All women in the puerpera period (who gave consent)
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Antenatal pregnancy classesAt least three comprehensive full-day educational program covering all the stages of pregnancy. | Behavioural | Antenatal Classes Received |
Primary outcome
Postpartum Depression
Time frame: Change between the 4th, 8th and 12th weeks of postpartum period
Postpartum Depression scores will be measured by Edinburgh Postpartum Scale (EDPS). The EDPS was developed to identify women who may have postpartum depression. Each answer is given a score of 0 to 3 . The maximum score is 30. The EPDS is a 10-item questionnaire. Women are asked to answer each question in terms of the past seven days. A score is calculated by adding the individual items as indicated A score of more than 10 suggests minor or major depression may be present.
4 secondary outcomes
Genital self-image
Time frame: At 4th, 8th and 12th week of postpartum period
sleep disorders
Time frame: At 4th, 8th and 12th week of postpartum period
breast-feeding
Time frame: At 4th, 8th and 12th week of postpartum period
socio-economic-demographical features
Time frame: At 4th postpartum week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Background: PubMed 21569372Lanes A, Kuk JL, Tamim H. Prevalence and characteristics of postpartum depression symptomatology among Canadian women: a cross-sectional study. BMC Public Health. 2011 May 11;11:302. doi: 10.1186/1471-2458-11-302.
- Individual participant dataSharing planned: Undecided
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.
Murat Yassa, MD principal investigator
Bartin State Hospital
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 and Sleep Disorder, run by Bartin State Hospital at 1 site in Turkey (Türkiye).
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 23 Apr 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 Turkey (Türkiye). 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?
Contact Murat Yassa, MD (+905335106312, murat.yassa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Depression (time frame: Change between the 4th, 8th and 12th weeks of postpartum period). 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 NCT03763435, which also lists 1 linked publication.
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 23 Apr 2019.