Empowering MothersEmpoweringNCT07900932
Empowering First-Time Mothers
A study testing digital lactation nursing support program in people with Empowering Mothers, run by Tanta University at 2 sites in Egypt.
Trial summary
This randomized controlled trial aims to evaluate the effect of digital lactation nursing support on breastfeeding achievement and maternal-infant outcomes among first-time mothers. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Empowering Mothers
- What is being tested?
- digital lactation nursing support program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2025to 30 Sep 2025
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First-time pregnant women (primigravida).
- Women in the third trimester of pregnancy.
- Women who are literate.
- Women who own a smartphone capable of installing and using the required digital applications.
- Women with a singleton, viable, term pregnancy without identified fetal congenital anomalies.
- Women without medical or psychological disorders that meet the study's exclusion criteria.
- Women willing to participate and provide written informed consent.
Who cannot join
- Multigravida women.
- Women who are illiterate.
- Women with multiple pregnancies.
- Women with identified fetal congenital anomalies.
- Women with medical or psychological disorders
- Women who do not have access to a compatible smartphone.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Tanta University Hospital
Tanta, Gharbia Governorate
The study was carried out within the antenatal and postnatal outpatient units of three prominent hospitals in Tanta City, which together serve as central hubs for maternal and child health services. These included Tanta University Hospital, functioning u
Tanta
About this study
Official title: Empowering First-Time Mothers: The Effect of Digital Lactation Nursing Support on Breastfeeding Achievement and Maternal-Infant Outcomes
This randomized controlled trial aims to evaluate the effect of digital lactation nursing support on breastfeeding achievement and maternal-infant outcomes among first-time mothers.
Read the detailed description
The study evaluates a digital lactation nursing support intervention delivered through online educational sessions and ongoing communication using digital platforms. The intervention is designed to provide breastfeeding education, address mothers' questions and concerns, and support breastfeeding initiation and continuation during the postpartum period.
Eligible first-time mothers are assigned to an intervention group receiving digital lactation nursing support in addition to standard care or a control group receiving standard care alone. The intervention includes four structured online educational sessions during the last month of pregnancy, followed by continued breastfeeding support through WhatsApp for three months after delivery.
Study outcomes include breastfeeding knowledge, early initiation of breastfeeding, exclusive breastfeeding, maternal-infant bonding and attachment, and maternal satisfaction with digital lactation support. Outcomes are assessed after delivery and at three months postpartum, according to the study protocol
- Conditions
- Empowering Mothers
- Being tested
- digital lactation nursing support program
- Keywords
- digital lactation, nursing support, maternal-infant outcomes.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital lactation nursing support programBehavioural
A structured digital lactation nursing support program based on self-efficacy principles. The intervention was delivered through four synchronous online educational sessions using Zoom, conducted once weekly over four consecutive weeks during the last month of pregnancy. Each session lasted approximately 30-45 minutes, and participants were organized into subgroups of approximately 10 women.
The sessions covered: (1) the benefits of breastfeeding for mothers and infants and the importance of early initiation; (2) breast milk composition and breastfeeding techniques; (3) factors influencing breastfeeding success, anticipated challenges, and coping strategies; and (4) recognition and management of common breastfeeding problems.
Educational materials included PowerPoint presentations, instructional videos, animations, scenario-based discussions, and an electronic handbook. WhatsApp was used for sharing materials, interactive discussions, clarification of information, and individualized
| Study group | Role | What they receive |
|---|---|---|
| Digital Lactation Nursing Support group (intervention group) | Active comparator | Participants assigned to the digital lactation nursing support group received standard hospital care plus a structured digital lactation nursing support program. The program included four weekly, synchronous online educational sessions delivered via Zoom during the last month of pregnancy, with each session lasting approximately 30-45 minutes. WhatsApp was used to share educational materials, facilitate interactive discussions, answer breastfeeding-related questions, and provide individualized guidance. Individual breastfeeding support continued via WhatsApp for three months postpartum Receives: Behavioral: digital lactation nursing support program |
| Standard Hospital Care Group (control goup) | No intervention | Participants assigned to the control group received standard hospital care without the additional structured digital lactation nursing support program. Standard care was provided according to the routine hospital protocols at the participating hospitals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of primigravida women about breast feeding
Total score on the breastfeeding knowledge section of the structured questionnaire, ranging from 0 to 38, with higher scores indicating greater breastfeeding knowledge.
including its definition, benefits for both the infant and the mother, different types of breast milk, and the role and effectiveness of colostrum. It also addressed the recommended time for initiating breastfeeding, its optimal duration, and practical components such as proper techniques and breastfeeding positions. Furthermore, the tool examined knowledge regarding the indicators of adequate, insufficient, and excessive breastfeeding. In addition, it explored awareness of common breastfeeding related problems as breast engorgement, cracked nipples, and inverted nipples highlighting for each (their definition, risk factors, signs and symptoms, possible complications, effects on the infant, and appropriate maternal self-care practices for relief.).
Measured: During the third trimester of pregnancy), immediately after delivery, and at 3 months postpartum.
Secondary outcomes (3)
The Postpartum Bonding Questionnaire
This tool consisted of 25 items designed to evaluate maternal attitudes toward their newborns. Each item offers six response options, ranging from "always" to "never." For positively worded statements, responses are scored from 0 (always) to 5 (never), whereas negatively worded statements are scored in reverse order, from 5 (always) to 0 (never). The total score ranges from 0 to 125, with higher scores indicating poorer bonding.
Measured: Immediately after delivery and at 3 months postpartum.
Mother infant attachment scale
It comprises 15 statements that reflect different maternal attitudes and perceptions toward the child, Responses are rated on a five- point Likert scale ranging from strongly agree to strongly disagree. Each item is scored from 1 to 5, with 5 representing the most favorable response and 1 representing the least favorable response. The total score ranges from 15 to 75. Higher total scores indicate poorer mother-infant attachment, whereas lower scores reflect stronger attachment.
Measured: immediately after delivery and at 3 months follow-up
Maternal Satisfaction of Telelactation
The tool comprised 11 items that explored multiple dimensions of telelactation. Responses were rated on a three-point Likert scale: 3 = satisfied, 2 = partially satisfied, and 1 = not satisfied. Total scores ranged from 11 to 33 and were categorized as not satisfied (<18), partially satisfied (18 to <25), and satisfied (≥25).
Measured: at 3-month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Empowering MothersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 200 primigravida women were randomly randomized into intervention and control groups. The intervention group received a digital lactation nursing support program using WhatsApp and Zoom. The program consisted of four structured online training sessions, delivered weekly over four weeks in the last month of pregnancy, each lasting approximately 30-45 minutes long. Lactation support and ongoing communication were provided over WhatsApp and continued for 3 months postpartum. Outcomes were assessed immediately after birth and again at 3 months postpartum using validated instruments of breastfeeding knowledge, mother-infant bonding and attachment, and maternal satisfaction of tele-lactation.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Reda Elkest, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900932
- Sponsor's protocol ID
- 762-1-2025
- Acronym
- Empowering
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data is available with corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering First-Time Mothers: The Effect of Digital Lactation Nursing Support on Breastfeeding Achievement and Maternal-Infant Outcomes
- ClinicalTrials.gov ID
- NCT07900932
- Acronym / sponsor ID
- Empowering / 762-1-2025
- Conditions
- Empowering Mothers
- Keywords
- digital lactation, nursing support, maternal-infant outcomes.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 28 Oct 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 randomized controlled trial aims to evaluate the effect of digital lactation nursing support on breastfeeding achievement and maternal-infant outcomes among first-time mothers.
Detailed description
The study evaluates a digital lactation nursing support intervention delivered through online educational sessions and ongoing communication using digital platforms. The intervention is designed to provide breastfeeding education, address mothers' questions and concerns, and support breastfeeding initiation and continuation during the postpartum period.
Eligible first-time mothers are assigned to an intervention group receiving digital lactation nursing support in addition to standard care or a control group receiving standard care alone. The intervention includes four structured online educational sessions during the last month of pregnancy, followed by continued breastfeeding support through WhatsApp for three months after delivery.
Study outcomes include breastfeeding knowledge, early initiation of breastfeeding, exclusive breastfeeding, maternal-infant bonding and attachment, and maternal satisfaction with digital lactation support. Outcomes are assessed after delivery and at three months postpartum, according to the study protocol
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 200 primigravida women were randomly randomized into intervention and control groups. The intervention group received a digital lactation nursing support program using WhatsApp and Zoom. The program consisted of four structured online training sessions, delivered weekly over four weeks in the last month of pregnancy, each lasting approximately 30-45 minutes long. Lactation support and ongoing communication were provided over WhatsApp and continued for 3 months postpartum. Outcomes were assessed immediately after birth and again at 3 months postpartum using validated instruments of breastfeeding knowledge, mother-infant bonding and attachment, and maternal satisfaction of tele-lactation.
| Arm | Type | Receives |
|---|---|---|
| Digital Lactation Nursing Support group (intervention group) | Active comparator | Behavioral: digital lactation nursing support programParticipants assigned to the digital lactation nursing support group received standard hospital care plus a structured digital lactation nursing support program. The program included four weekly, synchronous online educational sessions delivered via Zoom during the last month of pregnancy, with each session lasting approximately 30-45 minutes. WhatsApp was used to share educational materials, facilitate interactive discussions, answer breastfeeding-related questions, and provide individualized guidance. Individual breastfeeding support continued via WhatsApp for three months postpartum |
| Standard Hospital Care Group (control goup) | No intervention | –Participants assigned to the control group received standard hospital care without the additional structured digital lactation nursing support program. Standard care was provided according to the routine hospital protocols at the participating hospitals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First-time pregnant women (primigravida).
- Women in the third trimester of pregnancy.
- Women who are literate.
- Women who own a smartphone capable of installing and using the required digital applications.
- Women with a singleton, viable, term pregnancy without identified fetal congenital anomalies.
Key exclusion criteria (6 listed)
- Multigravida women.
- Women who are illiterate.
- Women with multiple pregnancies.
- Women with identified fetal congenital anomalies.
- Women with medical or psychological disorders
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 |
|---|---|---|
| digital lactation nursing support programA structured digital lactation nursing support program based on self-efficacy principles. The intervention was delivered through four synchronous online educational sessions using Zoom, conducted once weekly over four consecutive weeks during the last month of pregnancy. Each session lasted approximately 30-45 minutes, and participants were organized into subgroups of approximately 10 women. The sessions covered: (1) the benefits of breastfeeding for mothers and infants and the importance of early initiation; (2) breast milk composition and breastfeeding techniques; (3) factors influencing breastfeeding success, anticipated challenges, and coping strategies; and (4) recognition and management of common breastfeeding problems. Educational materials included PowerPoint presentations, instructional videos, animations, scenario-based discussions, and an electronic handbook. WhatsApp was used for sharing materials, interactive discussions, clarification of information, and individualized | Behavioural | Digital Lactation Nursing Support group (intervention group) |
Primary outcome
Knowledge of primigravida women about breast feeding
Time frame: During the third trimester of pregnancy), immediately after delivery, and at 3 months postpartum.
Total score on the breastfeeding knowledge section of the structured questionnaire, ranging from 0 to 38, with higher scores indicating greater breastfeeding knowledge. including its definition, benefits for both the infant and the mother, different types of breast milk, and the role and effectiveness of colostrum. It also addressed the recommended time for initiating breastfeeding, its optimal duration, and practical components such as proper techniques and breastfeeding positions. Furthermore, the tool examined knowledge regarding the indicators of adequate, insufficient, and excessive breastfeeding. In addition, it explored awareness of common breastfeeding related problems as breast engorgement, cracked nipples, and inverted nipples highlighting for each (their definition, risk factors, signs and symptoms, possible complications, effects on the infant, and appropriate maternal self-care practices for relief.).
3 secondary outcomes
The Postpartum Bonding Questionnaire
Time frame: Immediately after delivery and at 3 months postpartum.
Mother infant attachment scale
Time frame: immediately after delivery and at 3 months follow-up
Maternal Satisfaction of Telelactation
Time frame: at 3-month postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. data is available with corresponding author
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital lactation nursing support program in people with Empowering Mothers, run by Tanta University at 2 sites in Egypt.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knowledge of primigravida women about breast feeding (time frame: During the third trimester of pregnancy), immediately after delivery, and at 3 months postpartum.). 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 28 Oct 2026.