Engorgement Study With a Double Electric Breast Pump

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Foundation for Maternal Infant and Lactation Knowledge

ClinicalTrials.gov Identifier:

NCT01619371

First received: June 12, 2012

Last updated: June 13, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 12, 2012

Last Updated Date

June 13, 2012

Start Date ^ICMJE

March 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Engorgement Relief [ Time Frame: 10 minutes per subject ] [ Designated as safety issue: Yes ]

Relief of engorgement as measured by the engorgement scale.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01619371 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Engorgement Study With a Double Electric Breast Pump

Official Title ^ICMJE

Engorgement Study With the Simplisse Double Electric Breast Pump

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

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.

Condition ^ICMJE

Engorgement

Intervention ^ICMJE

Device: Simplisse Double Electric Breast Pump

Use of breast pump for 10 minutes.

Other Name: Simplisse Double Electric Breast Pump, 1005S

Study Group/Cohort (s)

Lactating women

Lactating women willing to use a breast pump.

Intervention: Device: Simplisse Double Electric Breast Pump

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01619371

Other Study ID Numbers ^ICMJE

2614

Has Data Monitoring Committee

Yes

Responsible Party

Foundation for Maternal Infant and Lactation Knowledge

Study Sponsor ^ICMJE

Foundation for Maternal Infant and Lactation Knowledge

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jimi Francis, MS,PhD,IBCLC

Foundation for Maternal Infant and Lactation Knowledge

Information Provided By

Foundation for Maternal Infant and Lactation Knowledge

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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