The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Disorder; Postpartum Depression; Breast Feeding; Self Esteem
• Intervention / Treatment: Behavioral: Antenatal pregnancy classes

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Turkey
  • Bartin, Turkey
    • Recruiting
    • Bartin State Hospital
    • Contact: Murat Yassa, MD
    • Sub-Investigator: Nahide YAZICI, Midwife

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; At least three comprehensive full-day educational program covering all the stages of pregnancy.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
socio-economic-demographical features	Social, economic and demographic features will be assessed by a structured non-validated data gathering form	At 4th postpartum week

Collaborators and Investigators

• Sponsor: Bartin State Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2018
• Primary Completion (Anticipated): June 15, 2019
• Study Completion (Anticipated): July 15, 2019

Study Registration Dates

• First Submitted: November 24, 2018
• First Submitted That Met QC Criteria: December 1, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 21, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: prevalence; sleep disorder; postpartum depression; breast-feeding; genital self-image
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Sleep Wake Disorders; Parasomnias; Depression, Postpartum
• Other Study ID Numbers: Bartin2018-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No