Primiparous Pregnant Women in the Last TrimesterNCT07547579
The Effect of Neonatal Care Education Given to Primiparous Mothers in the Last Trimester on Mothers' Self-Efficacy Perception, Prenatal and Maternal Bonding in the Early Postpartum Period
A study testing Newborn Care Education in people with Primiparous Pregnant Women in the Last Trimester, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted using a pre-test-post-test randomized controlled experimental design to investigate the effects of neonatal care education given to primiparous mothers in the last trimester on their self-efficacy perception, prenatal and maternal bonding in the early postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primiparous Pregnant Women in the Last Trimester
- What is being tested?
- Newborn Care Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 31 Dec 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being over 18 and under 35 years of age, Being in the last trimester of pregnancy (28-32 weeks of gestation) Having no communication barriers and being literate Single pregnancy Spontaneous conception Having applied to the Kars Harakani State Hospital Pregnancy School Agreeing to participate in the study
Who cannot join
- Chronic illness, High-risk pregnancy, Having a psychological disorder, Having applied to a Pregnancy School other than Harakani State Hospital.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study was conducted using a pre-test-post-test randomized controlled experimental design to investigate the effects of neonatal care education given to primiparous mothers in the last trimester on their self-efficacy perception, prenatal and maternal bonding in the early postpartum period. The study population consisted of pregnant women in the last trimester who applied to the Antenatal School of Kars Harakani State Hospital between November 2024 and November 2026. The study sample consisted of a total of 76 pregnant women, divided into an intervention group (n: 38) and a control group (n: 38). Data were collected using the "Personal Information Form", "General Self-Efficacy Scale", "Prenatal Attachment Inventory", and "Maternal Attachment Scale". The intervention group received training on newborn care. In the first phase of the study, a pre-test was administered to both the intervention and control groups. Following the pre-test, Newborn Care Training was conducted face-to-face with pregnant women in the experimental group in two 20-minute sessions, totaling 40 minutes, after which the pregnant women were given an educational booklet. After this training session, reinforcement training was conducted twice by telephone at one-week intervals, and their questions were answered. After the pre-test, at 36 weeks of gestation, both the intervention and control groups were contacted by telephone and the "General Self-Efficacy Scale" and "Prenatal Attachment Inventory" were administered as post-tests. Six weeks after delivery, the maternal attachment scale was administered to both the intervention and control groups.
- Being tested
- Newborn Care Education
- Keywords
- PREGNANCY, NEWBORN, PRENATAL, MATERNAL, SELF-EFFICACY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newborn Care EducationBehavioural
The newborn care education program includes information on breastfeeding, infant hygiene, umbilical cord care, infant safety, and basic newborn care practices. The education is provided during the third trimester of pregnancy. Allocation / Randomization Allocation: Randomized Randomization Description: Participants will be randomly assigned to the intervention group or the control group using a computer-generated randomization sequence with a 1:1 allocation ratio.
Masking (Blinding) Masking: None (Open Label) Masking Description (opsiyonel): This is an open-label study. Participants and investigators are aware of group assignment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group Intervention Type: Behavioral Name: Newborn Care Education Group | Active comparator | Primiparous women in their third trimester assigned to the intervention group will receive a structured newborn care education program in addition to completing the study questionnaires. Receives: Behavioral: Newborn Care Education |
| Control Group | No intervention | Primiparous women assigned to the control group will receive routine prenatal care and will complete the study questionnaires only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Self-Efficacy
Changes in maternal self-efficacy levels measured using the General Self-Efficacy Scale during the early postpartum period.
Measured: (between 24 and 41 weeks of pregnancy)
Secondary outcomes (2)
Prenatal Attachment
Changes in prenatal attachment levels measured using the Prenatal Attachment Inventory.
Measured: (between 24 and 41 weeks of pregnancy)
Maternal Attachment
Maternal attachment levels measured using the Maternal Attachment Scale during the early postpartum period.
Measured: 6th week after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primiparous Pregnant Women in the Last TrimesterStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to an intervention group and a control group. The intervention group will receive the behavioral/educational interventional in addition to completing questionnaires, while the control group will complete questionnaires only.
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YAĞMUR KOTANCI, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547579
- Sponsor's protocol ID
- KAÜ-YMRKTNCİ
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The privacy of personal data is respected in this study. Voluntary informed consent forms are obtained from participants. Therefore, the researcher does not share the participants' information.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neonatal Care Education Given to Primiparous Mothers in the Last Trimester on Mothers' Self-Efficacy Perception, Prenatal and Maternal Bonding in the Early Postpartum Period
- ClinicalTrials.gov ID
- NCT07547579
- Acronym / sponsor ID
- KAÜ-YMRKTNCİ
- Keywords
- PREGNANCY, NEWBORN, PRENATAL, MATERNAL, SELF-EFFICACY
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Apr 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 study was conducted using a pre-test-post-test randomized controlled experimental design to investigate the effects of neonatal care education given to primiparous mothers in the last trimester on their self-efficacy perception, prenatal and maternal bonding in the early postpartum period. The study population consisted of pregnant women in the last trimester who applied to the Antenatal School of Kars Harakani State Hospital between November 2024 and November 2026. The study sample consisted of a total of 76 pregnant women, divided into an intervention group (n: 38) and a control group (n: 38). Data were collected using the "Personal Information Form", "General Self-Efficacy Scale", "Prenatal Attachment Inventory", and "Maternal Attachment Scale". The intervention group received training on newborn care. In the first phase of the study, a pre-test was administered to both the intervention and control groups. Following the pre-test, Newborn Care Training was conducted face-to-face with pregnant women in the experimental group in two 20-minute sessions, totaling 40 minutes, after which the pregnant women were given an educational booklet. After this training session, reinforcement training was conducted twice by telephone at one-week intervals, and their questions were answered. After the pre-test, at 36 weeks of gestation, both the intervention and control groups were contacted by telephone and the "General Self-Efficacy Scale" and "Prenatal Attachment Inventory" were administered as post-tests. Six weeks after delivery, the maternal attachment scale was administered to both the intervention and control groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to an intervention group and a control group. The intervention group will receive the behavioral/educational interventional in addition to completing questionnaires, while the control group will complete questionnaires only.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group Intervention Type: Behavioral Name: Newborn Care Education Group | Active comparator | Behavioral: Newborn Care EducationPrimiparous women in their third trimester assigned to the intervention group will receive a structured newborn care education program in addition to completing the study questionnaires. |
| Control Group | No intervention | –Primiparous women assigned to the control group will receive routine prenatal care and will complete the study questionnaires only. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being over 18 and under 35 years of age, Being in the last trimester of pregnancy (28-32 weeks of gestation) Having no communication barriers and being literate Single pregnancy Spontaneous conception Having applied to the Kars Harakani State Hospital Pregnancy School Agreeing to participate in the study
Key exclusion criteria (1 listed)
- Chronic illness, High-risk pregnancy, Having a psychological disorder, Having applied to a Pregnancy School other than Harakani State Hospital.
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 |
|---|---|---|
| Newborn Care EducationThe newborn care education program includes information on breastfeeding, infant hygiene, umbilical cord care, infant safety, and basic newborn care practices. The education is provided during the third trimester of pregnancy. Allocation / Randomization Allocation: Randomized Randomization Description: Participants will be randomly assigned to the intervention group or the control group using a computer-generated randomization sequence with a 1:1 allocation ratio. Masking (Blinding) Masking: None (Open Label) Masking Description (opsiyonel): This is an open-label study. Participants and investigators are aware of group assignment. | Behavioural | Intervention Group Intervention Type: Behavioral Name: Newborn Care Education Group |
Primary outcome
General Self-Efficacy
Time frame: (between 24 and 41 weeks of pregnancy)
Changes in maternal self-efficacy levels measured using the General Self-Efficacy Scale during the early postpartum period.
2 secondary outcomes
Prenatal Attachment
Time frame: (between 24 and 41 weeks of pregnancy)
Maternal Attachment
Time frame: 6th week after birth
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 23 Apr 2026.
- Individual participant dataSharing planned: No. The privacy of personal data is respected in this study. Voluntary informed consent forms are obtained from participants. Therefore, the researcher does not share the participants' information.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newborn Care Education in people with Primiparous Pregnant Women in the Last Trimester, run by Kafkas 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 23 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Self-Efficacy (time frame: (between 24 and 41 weeks of pregnancy)). 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 23 Apr 2026.