Breast FeedingNCT03178916
Breast Feeding Practice in High Risk Pregnant Women
An observational study of Breast Feeding, run by Assiut University at 1 site in Egypt.
Trial summary
The American Academy of Paediatrics recognizes multiple benefits of breastfeeding to both the term and premature newborn, particularly with regard to protection from infectious agents. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Breast Feeding
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 31 Dec 2020
- Phase
- Observational
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients attending Sohag general hospital
Who may be able to join
- Diabetes mellitus.
- Cardiac disease.
- Essential hypertension.
- Chronic chest disease, and/or chronic TB infection.
- Chronic hepatitis.
- Neurologic disease.
Show all 9Show fewer
- Anaemia (Hemoglobin <10 gm/dL).
- Thyroid disease.
- Multiple pregnancy.
Who cannot join
- pregnant women < 34 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
The American Academy of Paediatrics recognizes multiple benefits of breastfeeding to both the term and premature newborn, particularly with regard to protection from infectious agents. Studies have demonstrated decreased rates of bacteraemia, meningitis, respiratory and urinary tract infections, necrotizing enterocolitis, and otitis media among breastfed infants
- Conditions
- Breast Feeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low risk pregnant women | evaluation of the efficacy of breastfeeding Low risk pregnant women | |
| high risk pregnant women | evaluation of the efficacy of breastfeeding high risk pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of breast feeding women during pregnancy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Jul 2017
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
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.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178916
- Sponsor's protocol ID
- BFHRP
- Status last verified
- Apr 2021
- First submitted
- 6 Jun 2017
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Feeding Practice in High Risk Pregnant Women
- ClinicalTrials.gov ID
- NCT03178916
- Acronym / sponsor ID
- BFHRP
- Conditions
- Breast Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Jun 2017 (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.
The American Academy of Paediatrics recognizes multiple benefits of breastfeeding to both the term and premature newborn, particularly with regard to protection from infectious agents. Studies have demonstrated decreased rates of bacteraemia, meningitis, respiratory and urinary tract infections, necrotizing enterocolitis, and otitis media among breastfed infants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low risk pregnant women | – | –evaluation of the efficacy of breastfeeding Low risk pregnant women |
| high risk pregnant women | – | –evaluation of the efficacy of breastfeeding high risk pregnant women |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients attending Sohag general hospital
Key inclusion criteria (9 listed)
- Diabetes mellitus.
- Cardiac disease.
- Essential hypertension.
- Chronic chest disease, and/or chronic TB infection.
- Chronic hepatitis.
Key exclusion criteria (1 listed)
- pregnant women < 34 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of breast feeding women during pregnancy
Time frame: 6 months
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 23 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding, run by Assiut University at 1 site 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 9 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: finished, as of the sponsor's last update on 23 Apr 2021. 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 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?
The number of breast feeding women during pregnancy (time frame: 6 months). 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 23 Apr 2021.