- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346482
Determining the Effect of Midwife-Led Safe Infant Care Training for Pregnant Women on Awareness of Sudden Infant Death Syndrome and Home Accidents (Infant Care)
January 16, 2026 updated by: Ayseren Cevik, Cukurova University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This research is designed as a randomized controlled experimental study.
The research will be conducted in the NST unit located in the Marsa Obstetrics and Gynecology Annex Building of Seyhan State Hospital between the specified dates.
It has been determined that 60 participants should be included in the intervention group and 60 in the control group.
Primiparous pregnant women ≥32 weeks of gestation will be included in the study.
The study will be conducted in two interviews.
The pre-test will be administered at the first meeting with the pregnant woman, and the post-test will be administered in the second week postpartum.
The independent variables of the study are safe infant care education, and the demographic and obstetric characteristics of the pregnant women.
The dependent variables are awareness of sudden infant death syndrome and scores on the home accident awareness scale for mothers.
After normality tests are performed, univariate and multivariate analyses appropriate to the data set will be performed, and a significance level of p<0.05 will be considered.
The Statistical Programme for Social Science 22 (SPSS) will be used for data analysis.
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayseren Cevik, PhD
- Phone Number: 1129 +90 (322) 338 64 84
- Email: acevik@cu.edu.tr
Study Contact Backup
- Name: Cagla Kilic, Msc student
- Phone Number: 1124 +90 (322) 338 64 84
- Email: cagla.kilic15@outlook.com
Study Locations
-
-
Saricam
-
Adana, Saricam, Turkey (Türkiye), 01330
- Cukurova University Faculty of Health Sciences Department of Midwifery
-
Contact:
- Ayseren Cevik, PhD
- Phone Number: 1129 +903223386484
- Email: acevik@cu.edu.tr
-
Contact:
- Cagla Kilic, Msc Student
- Phone Number: 1124 +903223386484
- Email: cagla.kilic15@outlook.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Diagnosed high-risk pregnancy
- Diagnosed mental health condition
- Having previously received training/course in safe infant care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
No Intervention: Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Home Accident Awareness Scale for Mothers
Time Frame: pre-intervention, immediately after the intervention, after 2 week
|
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
Time Frame: pre-intervention, immediately after the intervention, after 2 week
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 16, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 20, 2027
Study Registration Dates
First Submitted
January 8, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Estimated)
January 16, 2026
Study Record Updates
Last Update Posted (Actual)
January 20, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 96/160 (14.11.2025)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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