Engorgement Study With a 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.

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Key information

Conditions

Engorgement Behavior Breast Feeding Breast Milk Expression Cardiovascular Diseases Feeding Behavior Hyperemia Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Newborn Care Center Clinic

Reno, Nevada, 89502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simplisse Double Electric Breast Pump

Device

Use of breast pump for 10 minutes.

Other names: Simplisse Double Electric Breast Pump, 1005S

Primary outcomes

Engorgement Relief

Time frame: 10 minutes per subject

Relief of engorgement as measured by the engorgement scale.

Sponsors and collaborators

Lead sponsor

Foundation for Maternal Infant and Lactation Knowledge

Other

Registry information

Official study title

Engorgement Study With the Simplisse Double Electric Breast Pump

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jun 14, 2012
Registry last updated: Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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