Empowering First-Time Mothers (Empowering)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt
- 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
-
-
Gharbia Governorate
-
Tanta, Gharbia Governorate, Egypt
- Tanta University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Digital Lactation Nursing Support group (intervention group)
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 |
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 |
|
No Intervention: Standard Hospital Care Group (control goup)
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.). |
During the third trimester of pregnancy), immediately after delivery, and at 3 months postpartum.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Postpartum Bonding Questionnaire
Time Frame: Immediately after delivery and at 3 months postpartum.
|
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. |
Immediately after delivery and at 3 months postpartum.
|
|
Mother infant attachment scale
Time Frame: immediately after delivery and at 3 months follow-up
|
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. |
immediately after delivery and at 3 months follow-up
|
|
Maternal Satisfaction of Telelactation
Time Frame: at 3-month postpartum
|
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). |
at 3-month postpartum
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 762-1-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
data is available with corresponding author
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.