The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression

Sleep Disorder Clinical Trial

Official title:

The Effects of Pregnancy Classes on Postpartum Depression and Contributing Factors to Postpartum Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03763435
• Other study ID #: Bartin2018-3
• Status: Recruiting
• Start date: December 7, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: April 2019
• Source: Bartin State Hospital
• Contact: Murat Yassa, MD
• Phone: +905335106312
• Email: murat.yassa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Breast Feeding
• Depression
• Depression, Postpartum
• Depressive Disorder
• Parasomnias
• Postpartum Depression
• Self Esteem
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Behavioral:
• Antenatal pregnancy classes
At least three comprehensive full-day educational program covering all the stages of pregnancy.

Locations

Country	Name	City	State
Turkey	Bartin State Hospital	Bartin

Sponsors (1)

Lead Sponsor	Collaborator
Bartin State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change between the 4th, 8th and 12th weeks of postpartum period
Secondary	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.	At 4th, 8th and 12th week of postpartum period
Secondary	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).	At 4th, 8th and 12th week of postpartum period
Secondary	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.	At 4th, 8th and 12th week of postpartum period
Secondary	socio-economic-demographical features	Social, economic and demographic features will be assessed by a structured non-validated data gathering form	At 4th postpartum week