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CompletedNCT07900932EmpoweringUpdated Nov 4, 2026

Empowering First-Time Mothers

An interventional study of digital lactation nursing support program in Breast Feeding and Maternal and Infant Bonding, sponsored by Tanta University. Completed at 2 sites in Egypt. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Tanta University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2025, registered Oct 2026).
Updated Nov 4, 2026Study documents postedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Breast Feeding with a site in Egypt — 4 open to participants now, 4 under way, none of them phase 3. Breast Feeding · Egypt.

Enrollment
Largest of 12
200 · median 87
Started
2025
with 4 others
No phase
12 of 14
4 open now
Registered
13th of 14
by date
Lead sponsor
1 of 14
Tanta University

Among the 14 studies in Breast Feeding with a site in Egypt, this one has the largest enrollment of the 12 interventional ones, is one of 5 that started in 2025, is one of 12 with no phase, and was the 13th registered.

By phase

14 studies; the count open now beside each. This study's row is marked.

No phasethis study12 · 4 open
Observational2 · 0 open

By the year they started

First in 2003; this study’s year is marked. 5 started in 2025.

Size and results

Median enrollment 87 across the 12 interventional studies, 170 across the 2 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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 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

03

Conditions studied

  • Breast Feeding
  • Maternal and Infant Bonding

Browse trials for

Keywords

  • digital lactation
  • nursing support
  • maternal-infant outcomes
  • telehealth
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • 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

    Behavioral: digital lactation nursing support program

  • 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.

Interventions

  • Behavioraldigital lactation nursing support program

    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

06

What researchers measure

Primary outcomes

  1. 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.).

    Time frame: During the third trimester of pregnancy), immediately after delivery, and at 3 months postpartum.

Secondary outcomes

  1. 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.

    Time frame: Immediately after delivery and at 3 months postpartum.

  2. 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.

    Time frame: immediately after delivery and at 3 months follow-up

  3. 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).

    Time frame: at 3-month postpartum

07

Study locations

2 sites
  • Tanta University Hospital
    Tanta, Gharbia Governorate, 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
    Tanta, Egypt
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — data is available with corresponding author

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2025 to primary completion in Jan 2025, 0 months.

Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 0 months is below that.

Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Oct 28, 2026
StartActual
Jan 1, 2025
Primary completionActual
Jan 1, 2025
CompletionActual
Sep 30, 2025
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry
Oct 28, 2026
Show all 3 updates
  1. Nov 4, 2026
  2. Oct 29, 2026
    Minor edits only
    + 2 other changes: index terms and conditions
  3. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07900932
Lead sponsor
Tanta University
Responsible party
Hend Reda Elkest (assistant professor, Tanta University) — Principal investigator
First posted
Oct 28, 2026
Start date
Jan 1, 2025
Primary completion
Jan 1, 2025
Completion
Sep 30, 2025
Last update
Nov 4, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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