Prenatal Breastfeeding Education to Reduce Nipple Pain (BEST)

September 23, 2023 updated by: University of California, Davis
This study is a randomized controlled trial to evaluate the effectiveness of different approaches to prenatal teaching of infant latch.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • Sutter Davis Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women who intend to breastfeed their infants
  • Single infant
  • Resides in catchment area
  • Has phone
  • Speaks English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Education on Infant-led latching
Behavioral: Education
Education on Infant-led latching
No Intervention: Standard education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nipple pain day 3 postpartum
Time Frame: Day 3 postpartum
Day 3 postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
Breastfeeding status day 30 postpartum
Time Frame: Day 30 postpartum
Day 30 postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Centers for Disease Control and Prevention
Association of American Medical Colleges

Investigators

  • Principal Investigator: Caroline J Chantry, M.D., University of California, Davis
  • Principal Investigator: Kathryn G Dewey, Ph.D., University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimated)

March 24, 2010

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 23, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200614137-5
  • MM-0844-05/05 (Other Grant/Funding Number: American Association of Medical Colleges)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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