CClinicalTrials.gg
Status unknownNCT03763435Updated Apr 23, 2019

The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression

An observational study in Postpartum Depression, Sleep Disorder and Breast Feeding, sponsored by Bartin State Hospital. Status unknown at 1 site in Turkey. Open to female participants. Per ClinicalTrials.gov, last updated 2019-04-23.

Sponsored by Bartin State Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
400
Sex
Female
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Study 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. 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

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Conditions studied

  • Postpartum Depression
  • Sleep Disorder
  • Breast Feeding
  • Self Esteem

Keywords

  • postpartum depression
  • sleep disorder
  • genital self-image
  • breast-feeding
  • prevalence
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In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's planned enrollment of 400 is above the median of 114 across 215 observational studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Bartin State Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All women who gave birth in Bartin State Hospital (the only one hospital in the city) after October 2018. for three months.

Inclusion criteria

  • All women in the puerpera period (who gave consent)

Exclusion criteria

Exclusion Criteria:

  • None.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Antenatal Classes Received

    Women who are involved into at least 3 comprehensive session of Antenatal pregnancy classes (educational) during the prenatal period.

    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.

Interventions

  • BehavioralAntenatal pregnancy classes

    At least three comprehensive full-day educational program covering all the stages of pregnancy.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change between the 4th, 8th and 12th weeks of postpartum period

Secondary outcomes

  1. 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.

    Time frame: At 4th, 8th and 12th week of postpartum period

  2. 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).

    Time frame: At 4th, 8th and 12th week of postpartum period

  3. 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.

    Time frame: At 4th, 8th and 12th week of postpartum period

  4. socio-economic-demographical features

    Social, economic and demographic features will be assessed by a structured non-validated data gathering form

    Time frame: At 4th postpartum week

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Study locations

1 of 1 sites recruiting
  • Bartin State Hospital
    Bartin, Turkey
    • Murat Yassa, MD · Contact
    • Nahide YAZICI, Midwife · Sub investigator
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03763435
Lead sponsor
Bartin State Hospital
Responsible party
Murat Yassa (Principal Investigator, Bartin State Hospital) — Principal investigator
First posted
Dec 4, 2018
Start date
Dec 7, 2018
Primary completion
Jun 15, 2019 (estimated)
Completion
Jul 15, 2019 (estimated)
Last update
Apr 23, 2019

Study contacts

Murat Yassa, MD
Contact
murat.yassa@gmail.com
+905335106312
Murat Yassa, MD
principal investigator · Bartin State Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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