NCT06922682

Brief Summary

Sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. The study aims examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

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

April 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 3, 2025

Last Update Submit

April 3, 2025

Conditions

Keywords

Sudden Infant Deathnewbornmotherrisk factors

Outcome Measures

Primary Outcomes (1)

  • Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire

    Questionnaire, developed by authors consists of 2 sections. First section aims to determine knowledge level of pregnant women about sudden infant death syndrome. Questionnaire consisting of 17 questions are answered as true, false, or I do not know. Items answered as "True" are scored 1 point, whereas items answered as "False" or "I don't know" are scored as 0. Questionnaire includes reverse coded items. The lowest possible score in the questionnaire is 0 and the highest possible score is 17. The second section consists of questions aiming to determine the risky behaviors of pregnant women that may cause sudden infant death syndrome. A total of 26 questions in this section are answered as never (1 point), rarely (2 points), sometimes (3 points), often (4 points) and always (5 points). The questionnaire includes reverse coded items; the lowest and the highest possible scores in the questionnaire are 26 and 130, respectively.

    20 minutes before training, just after training and 2 month later

Study Arms (2)

Intervention Group

EXPERIMENTAL

Pregnant women in their 38th week of pregnancy and later, who visited the hospital to have their NST scans, were then invited to the training with the Risk Factors Triggering Sudden Infant Death Syndrome Training Booklet

Behavioral: Training with Sudden Infant Death Syndrome Training Booklet

Control Group

NO INTERVENTION

Pregnant women in this group were not provided a specific training on the risk factors triggering sudden infant death syndrome. The clinic has already offered a pregnancy school where routine prenatal care training is provided.

Interventions

Sudden Infant Death Syndrome Training Booklet was prepared. Prgenant women who agreed to participate were provided a face-to-face training on the risk factors triggering sudden infant death syndrome through the booklet. Following the educational session, they received the safe sleep handout to use at home and were informed that the researcher would call them two months later to check on their adherence to safe sleep practices. Following the training, participants were re-administered the Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire and the training booklet was given to them as a gift. Two months after the training, the pregnant women were contacted via phone and they were required to fill out the Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire once again.

Intervention Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women who were in the 38th week of their pregnancy and older,
  • Lived a healthy pregnancy,
  • Had no communication problems,
  • Can speak and understand Turkish,
  • Agreed to participate in the study were included.

You may not qualify if:

  • Pregnant women who were earlier than 38 weeks pregnant,
  • Had difficulty in communicating,
  • Were illiterate and unable to speak Turkish,
  • Who filled out the forms incompletely were not included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Gynecology and Children's Diseases Hospital in Turkey

Samsun, Black Sea Zone, 55100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sudden Infant Death

Condition Hierarchy (Ancestors)

Death, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsInfant Death

Study Officials

  • Hatice Uzsen, PHD

    Ondokuz Mayis Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: a parallel group, randomized, controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 10, 2025

Study Start

April 1, 2024

Primary Completion

July 1, 2024

Study Completion

July 30, 2024

Last Updated

April 10, 2025

Record last verified: 2025-04

Locations