NCT07563712

Brief Summary

This study looks at depression among mothers after childbirth (also called postpartum depression) in Mekelle City, Tigray, Ethiopia. Postpartum depression is a common mental health condition that can affect women after they give birth. It may cause sadness, loss of interest, fatigue, and difficulty caring for the baby. If not recognized and treated, it can affect both the mother and her child's health and well-being. The purpose of this study is to find out how common postpartum depression is among mothers visiting public health facilities for postnatal care and child immunization services and to identify factors that may increase the risk. Understanding these factors can help health professionals and policymakers improve support services for mothers. Mothers who come to selected health facilities for routine postnatal or immunization services will be invited to participate. Participation is voluntary. Those who agree will be asked to complete a questionnaire that includes questions about their mood, social support, economic conditions, and health status. The questionnaire does not include any personal identifiers, so participants' privacy will be protected. There are no direct medical risks involved in participating in this study. However, some questions may make participants feel emotional when reflecting on their experiences. Participants are free to skip any question or stop at any time. If a mother is found to have symptoms of depression, she will be advised to seek care and may be referred to appropriate health services. This study may not provide direct benefits to participants, but the findings will help improve understanding of maternal mental health in a post-conflict setting. The results can support the development of better screening, early detection, and support programs for postpartum depression in the community. Overall, this research aims to contribute to improving the health and well-being of mothers and their children by providing evidence that can guide future healthcare services and policies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

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

January 19, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 21, 2026

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postpartum Depression

    Presence of postpartum depression among mothers attending postnatal and immunization services, assessed using a standardized screening tool, the Edinburgh Postnatal Depression Scale (EPDS): scores ≥13 were considered to have postpartum depression

    At the time of interview during the postpartum period (within 6 weeks after delivery)

Secondary Outcomes (3)

  • Socio-demographic factors

    At the time of interview during the postpartum period (within 6 weeks after delivery)

  • Obstetric and reproductive factors

    At the time of interview during the postpartum period (within 6 weeks after delivery)

  • Psychosocial factors

    At the time of interview during the postpartum period (within 6 weeks after delivery)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen (self-identified female participants who have given birth)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of postpartum mothers who are attending postnatal care and immunization clinics in selected public health institutions in Mekelle City, Tigray, Ethiopia. These mothers include those who have recently given birth and are visiting health facilities for routine maternal and child health services during the study period. The population represents women in the postpartum period who are available at the selected facilities and meet the eligibility criteria for the study.

You may qualify if:

  • Postnatal women attending postnatal care or vaccination (EPI) services within six weeks of delivery at the selected public health institutions during the study period

You may not qualify if:

  • Women who had a serious illness that prevented participation.
  • Mothers who were unable to attend the selected facilities
  • Mothers who could not communicate effectively,
  • Mothers who had a documented history of severe mental disorders prior to pregnancy (e.g., bipolar disorder or schizophrenia),
  • Mothers who were actively using substances during the data collection period
  • Mothers who had refused to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mekelle general hospital, Yekatit 11 Hospital, Kassech Health Center, Semien Health Center, Adishimdihun Health Center

Mek'ele, Tigray, Ethiopia

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

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

Study Officials

  • Akebom Kidane Gebremichael, Doctor

    Mekelle University College of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 4, 2026

Study Start

January 19, 2025

Primary Completion

May 19, 2025

Study Completion

May 19, 2025

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

This is because the dataset contains sensitive health information related to maternal mental health, including postpartum depression status and related psychosocial variables. Although all identifiers will be removed, the nature of the data may still pose a risk of re-identification in a small or defined population. In addition, the current ethical approval and participant consent do not include provisions for public data sharing. Therefore, only aggregated results will be reported in publications, and access to the raw dataset will be restricted to the principal investigator and authorized research team members for the purpose of analysis.

Locations