NCT05356026

Brief Summary

Objective: To determine the effect of online postpartum follow-up on depression and postpartum adaptation. Design: A parallel-randomized-controlled study Setting: During 2021 in Turkey Participants: 52 women in the postpartum period Measurements: Data were collected through the Personal Information Form, the Follow-up Form, the Edinburgh Postpartum Depression Scale (EPDS), and the Postpartum Self-Assessment Scale (PSAS). The women in the experimental group were administered three follow-ups (education/consultancy) in line with the timing and content in the T.R. Ministry of Health Postpartum Care Management Guide (2014). The follow-ups were performed using the Zoom® program, which enabled video talk. The women in the control group received the routine follow-up and care provided by the hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

April 20, 2022

Last Update Submit

April 26, 2022

Conditions

Keywords

Postpartum depressionpostpartum adaptationonline follow-uppostpartum carenurse

Outcome Measures

Primary Outcomes (2)

  • Postpartum depression

    The Edinburgh Postpartum Depression Scale (The scale is a self-report scale that has one sub-scale and 10items rated on a 4-point Likert scale. The scores to be obtained from the scale range between 0 and 30. The cut-off point of the scale is 12, and women who have higher scores than the total cut-off point are considered to be in the risk group.)

    6 weeks (Test 1: first 24 hours of the postpartum period, Test 2: between the 30th and 42nd days of postpartum period)

  • Postpartum adaptation

    The Postpartum Self-Assessment Scale ((The scale aims to assess the adaptation of women in the postpartum period to maternity. The scale has 82 items rated on a 4-point Likert scale and has seven sub-scales with 10 to 13 items in each. These sub-scales are the quality of the relationship between partners, partners' perception of participation in childcare, gratification with the labor experience, satisfaction with life situations and circumstances, confidence in the ability to cope with the tasks of motherhood, satisfaction with motherhood, and infant care, and support for the maternal role from friends and other family members. The scores to be obtained from the scale range between 82 and 328. Lower scores indicate good compatibility in that area.)

    6 weeks (Test 1: first 24 hours of the postpartum period, Test 2: between the 30th and 42nd days of postpartum period)

Study Arms (2)

Online follow up group

EXPERIMENTAL

The women in the experimental group were administered three follow-ups (education/consultancy) in line with the timing and content in the T.R. Ministry of Health Postpartum Care Management Guide (2014). The follow-ups were performed using the Zoom® program, which enabled video talk.

Other: Online postpartum follow-up

Routine follow up group

NO INTERVENTION

The women in the control group received the routine follow-up and care provided by the hospital.

Interventions

The women in the experimental group were administered three follow-ups (education/consultancy) in line with the timing and content in the T.R. Ministry of Health Postpartum Care Management Guide (2014). The follow-ups were performed using the Zoom® program, which enabled video talk.

Online follow up group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women those,
  • aged 18 and over
  • at least literate
  • who have given a live birth
  • in the first 48-hour period of the postpartum period
  • who have the technical infrastructure to use the online education application (Zoom)

You may not qualify if:

  • Women those,
  • illiterate
  • those with a high-risk pregnancy diagnosis
  • those who do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 6450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 2, 2022

Study Start

March 10, 2021

Primary Completion

August 20, 2021

Study Completion

September 28, 2021

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations