NCT04129476

Brief Summary

This trail aims to evaluate the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression in southern Razavi Khorasan Province.

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
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

Same day

First QC Date

October 9, 2019

Last Update Submit

October 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postpartum Depression

    Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. It includes 10 questions and each question is scored from 0 to 3. The total score ranges from 0 to 30 and a score of 10-13 indicates mild postpartum depression while a score of 14-15 indicates moderate postpartum depression. Score of 16 or higher is considered as severe depression which necessitates introduction to a psychologist.

    Edinburgh Postnatal Depression Scale will be filled from baseline to 6 week

Secondary Outcomes (2)

  • Predisposing, reinforcing and enabling factors inventory

    Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.

  • General health questionnaire (GHQ)

    Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.

Study Arms (2)

Cooperative Education Program

EXPERIMENTAL

We explore the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression.

Behavioral: Cooperative Education Program based on Precede-Proceed Model

Control

NO INTERVENTION

We provide routine care for these people during pregnancy

Interventions

The study population is pregnant women in Gonabad city between 30 and 35 weeks of gestation. In the experimental group, the training program was based on the PRECEDE-PROCEDURE model, including training on anatomy and prenatal physiology, prenatal and postnatal care, prenatal and postnatal mental health, as well as prenatal and postnatal events, and Mothers' feelings and attitudes, as well as postpartum problems and strategies will be discussed. The training period is 60 minutes in 4 consecutive sessions. Predisposing, reinforcing and enabling factors inventory, General health questionnaire (GHQ), Edinburgh depression inventory Will be filled Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.

Cooperative Education Program

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent to participate in the research
  • Gestational age 30-35 weeks
  • Be literate
  • No history of depression or mental illness in the past
  • Healthy fetus on ultrasound

You may not qualify if:

  • Having a preterm birth
  • Refusal to attend training sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gonabad University of Medical Science

Gonābād, Khorasan Razavi, 985157223028, Iran

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

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

Study Officials

  • Baloochi

    Gonabad University of Medical Science

    STUDY CHAIR

Central Study Contacts

Atefeh Dehnoalian

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 16, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

October 16, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations