Primigravida WomenNCT06423534
Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia
A study testing Breastfeeding Health Educational Program in people with Primigravida Women, run by Alexandria University at 1 site in Saudi Arabia.
Trial summary
Being pregnant causes a mother and her child to form a maternal tie, and the birth of the child fills the mother with an immense amount of love and happiness. Breastfeeding is how a mother and infant make their initial touch. Read more about this study
- Who is it for?
- Ages 17 to 45 years, women only
- Conditions the study is for
- Primigravida Women
- What is being tested?
- Breastfeeding Health Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Mar 2024to 10 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primigravida mothers who regularly visit maternity hospitals at Hail and Bisha City.
- Primigravida mothers during last three trimester and 1 month after delivery
- No problems during pregnant and have a healthy baby
- Primigravida mothers who are not contraindicated to breastfeeding
Who cannot join
- Multigravida mothers and pregnant women during first and second trimester
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Faculty of Nursing, Hail university
Ha'il
Asmaa Ali, 543132470, a.alabd@uoh.edu.sa
About this study
Being pregnant causes a mother and her child to form a maternal tie, and the birth of the child fills the mother with an immense amount of love and happiness. Breastfeeding is how a mother and infant make their initial touch. Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby.
Read the detailed description
This study will be done to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.
- Conditions
- Primigravida Women
- Being tested
- Breastfeeding Health Educational Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding Health Educational ProgramBehavioural
Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby. Therefore, this study will be conducted to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.
| Study group | Role | What they receive |
|---|---|---|
| Study GROUP | Experimental | Each primigravida in the study group during the last three trimesters will receive three sessions of knowledge, breast care, and breastfeeding technique after filling out a questionnaire (pretest). During 1 month from delivery, we will conduct a post-test with them (after 2 weeks and after 4 weeks) to explore the effect of breastfeeding health educational programs on practices and breastfeeding self-efficacy Receives: Behavioral: Breastfeeding Health Educational Program |
| Control group | Active comparator | The control group was selected first and received a brochure leaflet delivered by the researcher. They didn't receive the health educational program Receives: Behavioral: Breastfeeding Health Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
A preformatted structured questionnaire
It was developed by Tella et al. (2016) and comprised 12 questions that were assessed in various areas under various breastfeeding techniques practice.
Measured: 3 months
Self-Efficacy Scale - Short-Form (BSES-SF)
It was adopted (Dennis, 2003) that assess maternal self-efficacy for breastfeeding throughout all stages of the study. The BSES-SF is a Likert scale with 14 items organized into two domains, namely: technical and intrapersonal thoughts.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start20 Mar 2024
- Primary completion15 Jul 2024 (estimated)
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primigravida WomenStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khedr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423534
- Sponsor's protocol ID
- H-2024-126
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AlAbd AMA, Marzouk SA, Hassan AIM, Khedr MA, Albaqawi HM, Alrashidi NA, Alshammari LS, Buta JB, Al Nawasreh SS. Empowering New Mothers: A Randomized Trial Exploring the Effect of a Nursing Educational Programme on Breastfeeding Practices and Self-Efficacy Among Primigravida in Saudi Arabia. Int J Nurs Pract. 2026 Apr;32(2):e70119. doi: 10.1111/ijn.70119.
PubMed 41782282
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia
- ClinicalTrials.gov ID
- NCT06423534
- Acronym / sponsor ID
- H-2024-126
- Conditions
- Primigravida Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 21 May 2024 (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.
Being pregnant causes a mother and her child to form a maternal tie, and the birth of the child fills the mother with an immense amount of love and happiness. Breastfeeding is how a mother and infant make their initial touch. Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby.
Detailed description
This study will be done to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study GROUP | Experimental | Behavioral: Breastfeeding Health Educational ProgramEach primigravida in the study group during the last three trimesters will receive three sessions of knowledge, breast care, and breastfeeding technique after filling out a questionnaire (pretest). During 1 month from delivery, we will conduct a post-test with them (after 2 weeks and after 4 weeks) to explore the effect of breastfeeding health educational programs on practices and breastfeeding self-efficacy |
| Control group | Active comparator | Behavioral: Breastfeeding Health Educational ProgramThe control group was selected first and received a brochure leaflet delivered by the researcher. They didn't receive the health educational program |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Primigravida mothers who regularly visit maternity hospitals at Hail and Bisha City.
- Primigravida mothers during last three trimester and 1 month after delivery
- No problems during pregnant and have a healthy baby
- Primigravida mothers who are not contraindicated to breastfeeding
Key exclusion criteria (1 listed)
- Multigravida mothers and pregnant women during first and second trimester
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 |
|---|---|---|
| Breastfeeding Health Educational ProgramBreastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby. Therefore, this study will be conducted to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program. | Behavioural | Control group, Study GROUP |
Primary outcome
A preformatted structured questionnaire
Time frame: 3 months
It was developed by Tella et al. (2016) and comprised 12 questions that were assessed in various areas under various breastfeeding techniques practice.
Self-Efficacy Scale - Short-Form (BSES-SF)
Time frame: 3 months
It was adopted (Dennis, 2003) that assess maternal self-efficacy for breastfeeding throughout all stages of the study. The BSES-SF is a Likert scale with 14 items organized into two domains, namely: technical and intrapersonal thoughts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 41782282AlAbd AMA, Marzouk SA, Hassan AIM, Khedr MA, Albaqawi HM, Alrashidi NA, Alshammari LS, Buta JB, Al Nawasreh SS. Empowering New Mothers: A Randomized Trial Exploring the Effect of a Nursing Educational Programme on Breastfeeding Practices and Self-Efficacy Among Primigravida in Saudi Arabia. Int J Nurs Pract. 2026 Apr;32(2):e70119. doi: 10.1111/ijn.70119.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Health Educational Program in people with Primigravida Women, run by Alexandria University at 1 site in Saudi Arabia.
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 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A preformatted structured questionnaire (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT06423534, which also lists 1 linked publication.
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 21 May 2024.