Breast Tissue Before And After Breastfeeding Or The Use O... | NCT01857778

Studies
Breast Tissue Before And After Breastfeeding Or The Use Of A Breast Pump

NCT01857778

Sponsor

Foundation for Maternal Infant and Lactation Knowledge

Status

Completed

Last Update Posted

May 20, 2013Estimated

Enrollment

28Actual

Phase

Not provided

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.

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2012Actual

First Submitted Date

May 16, 2013

First Submission Date that Met QC Criteria

May 16, 2013

First Posted Date

May 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2013

Last Update Posted Date

May 20, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicole McDowell, Researcher, Foundation for Maternal Infant and Lactation KnowledgePrincipal Investigator

Lead Sponsor

Foundation for Maternal Infant and Lactation KnowledgeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Label	Type	Description	Intervention Names
Lactating Women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breast Tissue Change	Lactating women used a 1 of 3 breast pumps or breastfed for 10 minutes.	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lactating women who were breastfeeding.

Exclusion Criteria:

Non breastfeeding or non lactating women.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Lactating women.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Jimi Francis, PhD	Foundation for M.I.L.K.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renown Medical Center		Reno	Nevada	89502	United States

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Jimi Francis, Researcher, Foundation for Maternal Infant and Lactation Knowledge

Unposted Events

Type	Date	Date Unknown
Release	May 21, 2013
Reset	Aug 26, 2013
Release	Jul 21, 2020

Violation Annotation

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

Estimated Results First Submitted Date

May 21, 2013

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 21, 2013			Aug 26, 2013
Jul 21, 2020			Aug 4, 2020

ID	Term
D001942	Breast Feeding
D061186	Breast Milk Expression

ID	Term
D005247	Feeding Behavior
D001519	Behavior