NCT03763435

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

November 24, 2018

Last Update Submit

April 21, 2019

Conditions

Keywords

postpartum depressionsleep disordergenital self-imagebreast-feedingprevalence

Outcome Measures

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.

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

Secondary Outcomes (4)

  • Genital self-image

    At 4th, 8th and 12th week of postpartum period

  • sleep disorders

    At 4th, 8th and 12th week of postpartum period

  • breast-feeding

    At 4th, 8th and 12th week of postpartum period

  • socio-economic-demographical features

    At 4th postpartum week

Study Arms (2)

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

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

Antenatal Classes Received

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartin State Hospital

Bartın, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 21569372BACKGROUND

MeSH Terms

Conditions

Depression, PostpartumSleep Wake DisordersBreast Feeding

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Murat Yassa, MD

    Bartin State Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2018

First Posted

December 4, 2018

Study Start

December 7, 2018

Primary Completion

June 15, 2019

Study Completion

July 15, 2019

Last Updated

April 23, 2019

Record last verified: 2019-04

Locations