NCT07346482

Brief Summary

This project is a pioneering study in determining the impact of midwife-led safe infant care training for pregnant women on awareness of sudden infant death syndrome (SIDS) and home accidents. Raising awareness and improving women's knowledge about SIDS and home accidents is expected to help reduce preventable infant deaths. If the effectiveness of this training is proven, integrating it into prenatal care programs would be a significant step towards improving maternal and child health.

Trial Health

63
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Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress24%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 8, 2026

Last Update Submit

January 16, 2026

Conditions

Infant DeathInfant CareMidwiferyEducationAccident at Home

Keywords

infantinfant deathmidwifery careaccidenteducation

Outcome Measures

Primary Outcomes (2)

  • Home Accident Awareness Scale for Mothers

    Items are scored on a scale of 1-5. As the scale score increases, mothers' awareness of household accidents will increase.

    pre-intervention, immediately after the intervention, after 2 week

  • Sudden Infant Death Syndrome Awareness Scale - Mother Form

    Items are scored on a scale of 1 to 5. As the score obtained from the scale increases, the awareness score decreases.

    pre-intervention, immediately after the intervention, after 2 week

Study Arms (2)

Experimental

EXPERIMENTAL

Following the pre-test, the intervention group will receive training on safe infant care. A final test will be administered via telephone in the second week postpartum.

Other: Education

Control

NO INTERVENTION

Standard care (Turkish Ministry of Health Prenatal Care Guide) will be applied during the follow-up care after the pre-test. A final test will be administered via telephone in the second week postpartum.

Interventions

EducationOTHER

The educational content consists of general information about sudden infant death syndrome and home accidents in children aged 0-3, as well as prevention methods.

Experimental

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the research
  • Being able to speak and understand Turkish
  • Being literate
  • Being a primiparous pregnant woman (due to the greater need for information) ≥36th week of pregnancy (because it is close to delivery and there is sufficient time to translate what they have learned into behavior)

You may not qualify if:

  • Diagnosed high-risk pregnancy
  • Diagnosed mental health condition
  • Having previously received training/course in safe infant care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University Faculty of Health Sciences Department of Midwifery

Adana, Saricam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infant Death

Interventions

Educational Status

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Ayseren Cevik, PhD

CONTACT

+90 (322) 338 64 84acevik@cu.edu.tr

Cagla Kilic, Msc student

CONTACT

+90 (322) 338 64 84cagla.kilic15@outlook.com

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

January 8, 2026

First Posted

January 16, 2026

Study Start

February 16, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 20, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)