Engorgement Study With a Double Electric Breast Pump | NCT01619371

Studies
Engorgement Study With a Double Electric Breast Pump

NCT01619371

Sponsor

Foundation for Maternal Infant and Lactation Knowledge

Status

Completed

Last Update Posted

Jun 14, 2012Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Engorgement

Interventions

Simplisse Double Electric Breast Pump

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

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

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

Mar 2011

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jun 12, 2012

First Submission Date that Met QC Criteria

Jun 13, 2012

First Posted Date

Jun 14, 2012Estimated

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

Jun 13, 2012

Last Update Posted Date

Jun 14, 2012Estimated

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

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lactating women		Lactating women willing to use a breast pump.	Device: Simplisse Double Electric Breast Pump

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simplisse Double Electric Breast Pump	Device	Use of breast pump for 10 minutes.	Lactating women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Engorgement Relief	Relief of engorgement as measured by the engorgement scale.	10 minutes per subject

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

first week postpartum seeking lactation management assistance for engorgement, identified as clinically engorged by health care practitioner.

Exclusion Criteria:

greater than one week postpartum
less than 18 years of age
non-English speakers
not willing to use double electric breast pump

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jimi Francis, MS,PhD,IBCLC	Foundation for Maternal Infant and Lactation Knowledge	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Newborn Care Center Clinic		Reno	Nevada	89502	United States

Label	URL
home page of sponsoring foundation	View source

Type	Date	Date Unknown
Release	May 16, 2013
Reset	Aug 12, 2013
Release	Jul 21, 2020
Reset	Aug 4, 2020

Submission Tracking

Estimated Results First Submitted Date

May 16, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 16, 2013			Aug 12, 2013
Jul 21, 2020

Condition Browse Module

MeSH Terms

ID	Term
D006940	Hyperemia
D061186	Breast Milk Expression
D001942	Breast Feeding

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided