RCT of Evening Primrose Oil for the Treatment of Breastfeeding Pain

Not Applicable

• Conditions: Breast Feeding
• Interventions: Dietary Supplement: Evening Primrose Oil; Dietary Supplement: Placebo

• Registration Number: NCT03876899
• Lead Sponsor: St. Luke's Hospital, Pennsylvania

Brief Summary

Breastfeeding related mastalgia is a common post-partum complaint. We propose a double-blind, randomized, placebo-controlled trial that investigates the use of Evening Primrose Oil in the treatment of breastfeeding related mastalgia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Last Update Submitted: 2019-03-14
• Study Start: 2019-03-15
• Study First Posted: 2019-03-15
• Last Update Posted: 2019-03-15
• Primary Completion: 2019-08-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• currently breastfeeding
• recent delivery within the trailing 60 days

Exclusion Criteria

• history of seizure disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evening Primrose Oil	Evening Primrose Oil	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Breastfeeding Related Mastalgia	7 days	Visual Pain Score

Secondary Outcome Measures

Name	Time	Method
Adverse events	7 days	Epistaxis, Change in perceived lochia flow.