Breast FeedingNCT06564922
Effects of Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding
A study testing Counselling in people with Breast Feeding and Counselling, run by Bule Hora University at 1 site in Ethiopia.
Trial summary
Breastfeeding is crucial for the health of both mothers and infants, promoting healthier populations and reducing long-term healthcare costs. To maximize these benefits, education, support, and effective policies are essential. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Counselling
- What is being tested?
- Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Jan 2023to 1 May 2023
- 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 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gave birth by spontaneous vaginal delivery
- Residents of either Yabelo or Bule Hora town hospital
- willing to participate in the study Exclusion Criteria
- Seriously ill and planned to move during the study period
- Stillbirth
- Neonatal death
- Gave birth cesarean delivery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding During First Month at Bule Hora University Teaching Hospital and Yabelo General Hospital, Oromia, Ethiopia
Breastfeeding is crucial for the health of both mothers and infants, promoting healthier populations and reducing long-term healthcare costs. To maximize these benefits, education, support, and effective policies are essential. This study aimed to evaluate the impact of immediate postpartum counseling on early initiation and exclusive breastfeeding rates in the pastoralist areas of Oromia, Ethiopia.
Hypothesis: Individualized immediate postnatal counselling improve exclusive breastfeeding practice.
Read the detailed description
Breastfeeding plays a crucial role in promoting the health and well-being of both mothers and their infants, contributing to healthier populations, and reducing long-term healthcare costs. Encouraging breastfeeding through education, support, and policies is essential for maximizing these benefits. This study aimed to evaluate the impact of immediate postpartum counseling on early initiation of breastfeeding rates and exclusive breastfeeding in Bule Hora and Yabelo Hospitals. A cluster randomized single-blinded trial was conducted on 224 pregnant women (112 for the intervention group and 112 for the control group) from January 1, 2023, to April 30, 2023. The effect of immediate postpartum counselling and its associated variables on early initiation and exclusive breastfeeding practices were evaluated using multiple logistic regressions. A p-value of less than 0.05, a 95% confidence interval, and an adjusted odd ratio were used to determine statistical significance.
- Conditions
- Breast Feeding, Counselling
- Being tested
- Counselling
- Keywords
- Breast feeding, Early initiation of breast feeding, Exclusive breast feeding, Immediate counselling, Randomized controlled trial, Oromia, Ethiopia
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounsellingOther
Counselling was given for treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Postnatal Counselling on Exclusive Breast Feeding | Experimental | Counseling on exclusive breastfeeding (EBF) emphasizes starting within the first hour after birth and maintaining it for six months. It covers feeding frequency, proper positioning, and attachment techniques to enhance breastfeeding effectiveness. Benefits include reduced neonatal infections and lower maternal disease risks. The counseling warns against mixed feeding, which can lead to increased infection susceptibility and malnutrition. It also highlights postpartum danger signs in newborns, such as fever and irritability, encouraging early medical intervention. This comprehensive approach aims to empower mothers with knowledge, promoting healthier breastfeeding practices and improving outcomes for both mother and child. Receives: Other: Counselling |
| Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding | No intervention | Usual counselling will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early initiation of breastfeeding
Mothers will be asked about their infant breastfeeding practices, specifically regarding the early initiation of breastfeeding. The practice of early infant breastfeeding initiation will be determined using the operational definition of those who started breastfeeding within one hour after birth, while those who did not initiate breastfeeding within the first hour will be categorized accordingly.
Measured: up to 1month
Secondary outcomes (2)
Breastfeeding frequency
Frequency of breast-feeding: This section describes the practice of mothers feeding their infants breast milk on demand. In this study, instances where mothers fed their babies according to their needs and the program guidelines were coded as "0," while instances where babies required feeding were coded as "1." Therefore, a code of "1" indicates that the mother frequently breastfed, whereas a code of "0" indicates that she did not frequently breastfeed.
Measured: up to 1 month
Mother knowledge and attitude
Knowledge was assessed by evaluating their understanding of the benefits of breastfeeding for both themselves and their newborns. This evaluation involved eight specific questions. Mothers who answered at or above the mean score were classified as knowledgeable, while those who scored below the mean were considered not knowledgeable.
Attitude: This study assesses attitudes through 10 questions on a five-point likert scale ranging from "strongly agree" to "strongly disagree." Responses are then simplified into a two-point scale (agree or disagree), with "1" assigned for agreement on positive questions and "0" for disagreement. The reverse applies for negative questions. A positive attitude is indicated by responses that meet or exceed the mean score for breastfeeding items, while scores below the mean indicate a negative attitude.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Jan 2023
- Primary completion30 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study will have two arms, i.e., intervention and control groups. The intervention group will receive immediate postnatal breastfeeding counselling and control group will receive routine care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bule Hora University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belda Negesa Beyene, Bule Hora University
- Investigators
- Belda N Beyene, MSc, Principal investigator, Bule Hora University, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564922
- Sponsor's protocol ID
- BuleHoraU
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding During First Month at Bule Hora University Teaching Hospital and Yabelo General Hospital, Oromia, Ethiopia
- ClinicalTrials.gov ID
- NCT06564922
- Acronym / sponsor ID
- BuleHoraU
- Conditions
- Breast Feeding, Counselling
- Keywords
- Breast feeding, Early initiation of breast feeding, Exclusive breast feeding, Immediate counselling, Randomized controlled trial, Oromia, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Bule Hora UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 21 Aug 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.
Breastfeeding is crucial for the health of both mothers and infants, promoting healthier populations and reducing long-term healthcare costs. To maximize these benefits, education, support, and effective policies are essential. This study aimed to evaluate the impact of immediate postpartum counseling on early initiation and exclusive breastfeeding rates in the pastoralist areas of Oromia, Ethiopia.
Hypothesis: Individualized immediate postnatal counselling improve exclusive breastfeeding practice.
Detailed description
Breastfeeding plays a crucial role in promoting the health and well-being of both mothers and their infants, contributing to healthier populations, and reducing long-term healthcare costs. Encouraging breastfeeding through education, support, and policies is essential for maximizing these benefits. This study aimed to evaluate the impact of immediate postpartum counseling on early initiation of breastfeeding rates and exclusive breastfeeding in Bule Hora and Yabelo Hospitals. A cluster randomized single-blinded trial was conducted on 224 pregnant women (112 for the intervention group and 112 for the control group) from January 1, 2023, to April 30, 2023. The effect of immediate postpartum counselling and its associated variables on early initiation and exclusive breastfeeding practices were evaluated using multiple logistic regressions. A p-value of less than 0.05, a 95% confidence interval, and an adjusted odd ratio were used to determine statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will have two arms, i.e., intervention and control groups. The intervention group will receive immediate postnatal breastfeeding counselling and control group will receive routine care.
| Arm | Type | Receives |
|---|---|---|
| Postnatal Counselling on Exclusive Breast Feeding | Experimental | Other: CounsellingCounseling on exclusive breastfeeding (EBF) emphasizes starting within the first hour after birth and maintaining it for six months. It covers feeding frequency, proper positioning, and attachment techniques to enhance breastfeeding effectiveness. Benefits include reduced neonatal infections and lower maternal disease risks. The counseling warns against mixed feeding, which can lead to increased infection susceptibility and malnutrition. It also highlights postpartum danger signs in newborns, such as fever and irritability, encouraging early medical intervention. This comprehensive approach aims to empower mothers with knowledge, promoting healthier breastfeeding practices and improving outcomes for both mother and child. |
| Individualized Immediate Postnatal Counselling on Exclusive Breast Feeding | No intervention | –Usual counselling will be given. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Gave birth by spontaneous vaginal delivery
- Residents of either Yabelo or Bule Hora town hospital
- willing to participate in the study Exclusion Criteria
- Seriously ill and planned to move during the study period
- Stillbirth
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CounsellingCounselling was given for treatment group. | Other | Postnatal Counselling on Exclusive Breast Feeding |
Primary outcome
Early initiation of breastfeeding
Time frame: up to 1month
Mothers will be asked about their infant breastfeeding practices, specifically regarding the early initiation of breastfeeding. The practice of early infant breastfeeding initiation will be determined using the operational definition of those who started breastfeeding within one hour after birth, while those who did not initiate breastfeeding within the first hour will be categorized accordingly.
2 secondary outcomes
Breastfeeding frequency
Time frame: up to 1 month
Mother knowledge and attitude
Time frame: up to 1 month
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 21 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Breast Feeding
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
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.
Belda N Beyene, MSc principal investigator
Bule Hora University, Ethiopia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling in people with Breast Feeding and Counselling, run by Bule Hora University at 1 site in Ethiopia.
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 0 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 21 Aug 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 Ethiopia. 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?
Early initiation of breastfeeding (time frame: up to 1month). 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 21 Aug 2024.