EngorgementNCT01619371
Engorgement Study With a Double Electric Breast Pump
An observational study of Engorgement, run by Foundation for Maternal Infant and Lactation Knowledge at 1 site in United States.
Trial summary
The purpose of this study is to analyze the effectiveness of an FDA approved Class II medical device, the Simplisse Double Electric Breast Pump, in relieving the symptoms of engorgement. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Engorgement
- What is being tested?
- Simplisse Double Electric Breast Pump
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to May 2011
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: First 20 women arriving at the Newborn Care Center clinic in Reno, Nevada during their first week postpartum seeking lactation management assistance for engorgement.
Who may be able to join
- first week postpartum seeking lactation management assistance for engorgement, identified as clinically engorged by health care practitioner.
Who cannot join
- greater than one week postpartum
- less than 18 years of age
- non-English speakers
- not willing to use double electric breast pump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Engorgement Study With the Simplisse Double Electric Breast Pump
The purpose of this study is to analyze the effectiveness of an FDA approved Class II medical device, the Simplisse Double Electric Breast Pump, in relieving the symptoms of engorgement.
- Conditions
- Engorgement
- Being tested
- Simplisse Double Electric Breast Pump
- Keywords
- breast pump, engorgement, lactation
- Medical subject headings
- Hyperemia, Breast Milk Expression, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplisse Double Electric Breast PumpDevice
Also called Simplisse Double Electric Breast Pump, 1005S
Use of breast pump for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Lactating women | Lactating women willing to use a breast pump. Receives: Device: Simplisse Double Electric Breast Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engorgement Relief
Relief of engorgement as measured by the engorgement scale.
Measured: 10 minutes per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EngorgementStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Maternal Infant and Lactation Knowledge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jimi Francis, MS,PhD,IBCLC, Principal investigator, Foundation for Maternal Infant and Lactation Knowledge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619371
- Sponsor's protocol ID
- 2614
- Status last verified
- Jun 2012
- First submitted
- 12 Jun 2012
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engorgement Study With the Simplisse Double Electric Breast Pump
- ClinicalTrials.gov ID
- NCT01619371
- Acronym / sponsor ID
- 2614
- Conditions
- Engorgement
- Keywords
- breast pump, engorgement, lactation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Foundation for Maternal Infant and Lactation KnowledgeUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Jun 2012 (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.
The purpose of this study is to analyze the effectiveness of an FDA approved Class II medical device, the Simplisse Double Electric Breast Pump, in relieving the symptoms of engorgement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactating women | – | Device: Simplisse Double Electric Breast PumpLactating women willing to use a breast pump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- First 20 women arriving at the Newborn Care Center clinic in Reno, Nevada during their first week postpartum seeking lactation management assistance for engorgement.
Key inclusion criteria (1 listed)
- first week postpartum seeking lactation management assistance for engorgement, identified as clinically engorged by health care practitioner.
Key exclusion criteria (4 listed)
- greater than one week postpartum
- less than 18 years of age
- non-English speakers
- not willing to use double electric breast pump
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 |
|---|---|---|
| Simplisse Double Electric Breast PumpAlso: Simplisse Double Electric Breast Pump, 1005SUse of breast pump for 10 minutes. | Device | Lactating women |
Primary outcome
Engorgement Relief
Time frame: 10 minutes per subject
Relief of engorgement as measured by the engorgement scale.
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 14 Jun 2012.
- home page of sponsoring foundationLink provided by the sponsor.
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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.
Jimi Francis, MS,PhD,IBCLC principal investigator
Foundation for Maternal Infant and Lactation Knowledge
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 Engorgement, 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 4 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 14 Jun 2012. 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?
Engorgement Relief (time frame: 10 minutes per subject). 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 14 Jun 2012.