Engorgement Study With a Double Electric Breast Pump

Engorgement Study With the Simplisse Double Electric Breast Pump

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01619371

Enrollment

Registered

2012-06-14

Start date

2011-03-31

Completion date

2011-05-31

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Engorgement

Keywords

breast pump, engorgement, lactation

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.

Interventions

DEVICESimplisse Double Electric Breast Pump

Use of breast pump for 10 minutes.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026