To Collect Measurements of the NippleNCT01857778
Breast Tissue Before And After Breastfeeding Or The Use Of A Breast Pump
An observational study of To Collect Measurements of the Nipple and To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Breastfeeding, run by Foundation for Maternal Infant and Lactation Knowledge at 1 site in United States.
Trial summary
There will be breast tissue changes after use of a breast pump. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- To Collect Measurements of the Nipple, To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Breastfeeding, To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Expressing Milk With 3 Different Electric Breast Pumps.
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2012
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Lactating women.
Who may be able to join
- Lactating women who were breastfeeding.
Who cannot join
- Non breastfeeding or non lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
There will be breast tissue changes after use of a breast pump.
- Conditions
- To Collect Measurements of the Nipple, To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Breastfeeding, To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Expressing Milk With 3 Different Electric Breast Pumps.
- Keywords
- Breastfeeding, Breast tissue, Breast pump
- Medical subject headings
- Breast Feeding, Breast Milk Expression
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 |
|---|---|---|
| Lactating Women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Tissue Change
Lactating women used a 1 of 3 breast pumps or breastfed for 10 minutes.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Collect Measurements of the NippleStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Maternal Infant and Lactation Knowledge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole McDowell, Foundation for Maternal Infant and Lactation Knowledge
- Investigators
- Dr. Jimi Francis, PhD, Principal investigator, Foundation for M.I.L.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857778
- Sponsor's protocol ID
- 1990
- Status last verified
- Oct 2011
- First submitted
- 16 May 2013
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Tissue Before And After Breastfeeding Or The Use Of A Breast Pump
- ClinicalTrials.gov ID
- NCT01857778
- Acronym / sponsor ID
- 1990
- Conditions
- To Collect Measurements of the Nipple, To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Breastfeeding, To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Expressing Milk With 3 Different Electric Breast Pumps.
- Keywords
- Breastfeeding, Breast tissue, Breast pump
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Foundation for Maternal Infant and Lactation KnowledgeUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 May 2013 (estimated)
- 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.
There will be breast tissue changes after use of a breast pump.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactating Women | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Lactating women.
Key inclusion criteria (1 listed)
- Lactating women who were breastfeeding.
Key exclusion criteria (1 listed)
- Non breastfeeding or non lactating women.
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
Breast Tissue Change
Time frame: 10 minutes
Lactating women used a 1 of 3 breast pumps or breastfed for 10 minutes.
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 20 May 2013.
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.
Dr. Jimi Francis, PhD principal investigator
Foundation for M.I.L.K.
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 To Collect Measurements of the Nipple and To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Breastfeeding, run by Foundation for Maternal Infant and Lactation Knowledge at 1 site in United States.
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 1 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 20 May 2013. 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 United States. 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?
Breast Tissue Change (time frame: 10 minutes). 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 20 May 2013.