Infant DeathInfant CareNCT07346482
Determining the Effect of Midwife-Led Safe Infant Care Training for Pregnant Women on Awareness of Sudden Infant Death Syndrome and Home Accidents
A study testing Education in people with Infant Death and Infant Care, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant Death, Infant Care, Midwifery
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Diagnosed high-risk pregnancy
- Diagnosed mental health condition
- Having previously received training/course in safe infant care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Cukurova University Faculty of Health Sciences Department of Midwifery
Adana, Saricam, 01330
Ayseren Cevik, PhD, +903223386484 ext. 1129, acevik@cu.edu.tr
Cagla Kilic, Msc Student, +903223386484 ext. 1124, cagla.kilic15@outlook.com
About this study
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.
Read the 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.
- Conditions
- Infant Death, Infant Care, Midwifery, Education, Accident at Home
- Being tested
- Education
- Keywords
- infant, infant death, midwifery care, accident, education
- Medical subject headings
- Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: pre-intervention, immediately after the intervention, after 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start16 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DeathStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayseren Cevik, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346482
- Sponsor's protocol ID
- 96/160 (14.11.2025)
- Acronym
- Infant Care
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Midwife-Led Safe Infant Care Training for Pregnant Women on Awareness of Sudden Infant Death Syndrome and Home Accidents
- ClinicalTrials.gov ID
- NCT07346482
- Acronym / sponsor ID
- Infant Care / 96/160 (14.11.2025)
- Conditions
- Infant Death, Infant Care, Midwifery, Education, Accident at Home
- Keywords
- infant, infant death, midwifery care, accident, education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: EducationFollowing 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Diagnosed high-risk pregnancy
- Diagnosed mental health condition
- Having previously received training/course in safe infant care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationThe educational content consists of general information about sudden infant death syndrome and home accidents in children aged 0-3, as well as prevention methods. | Other | Experimental |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Infant Death and Infant Care, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayseren Cevik, PhD (+90 (322) 338 64 84 ext. 1129, acevik@cu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home Accident Awareness Scale for Mothers (time frame: pre-intervention, immediately after the intervention, after 2 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.