Prenatal Breastfeeding Education to Reduce Nipple Pain | NCT01092156

Studies
Prenatal Breastfeeding Education to Reduce Nipple Pain

NCT01092156

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Sep 28, 2023Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Nipple Pain During Lactation

Interventions

Education

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MM-0844-05/05	Other Grant/Funding Number	American Association of Medical Colleges

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Mar 22, 2010

First Submission Date that Met QC Criteria

Mar 23, 2010

First Posted Date

Mar 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2023

Last Update Posted Date

Sep 28, 2023Actual

Name	Class
Association of American Medical Colleges	OTHER
Centers for Disease Control and Prevention	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a randomized controlled trial to evaluate the effectiveness of different approaches to prenatal teaching of infant latch.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Education on Infant-led latching	Active Comparator		Behavioral: Education
Standard education	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education	Behavioral	Education on Infant-led latching	Education on Infant-led latching

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nipple pain day 3 postpartum		Day 3 postpartum

Secondary Outcomes

Measure	Description	Time Frame
Breastfeeding status day 30 postpartum		Day 30 postpartum

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caroline J Chantry, M.D.	University of California, Davis	Principal Investigator
Kathryn G Dewey, Ph.D.	University of California, Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sutter Davis Hospital		Davis	California	95616	United States

Intervention Browse Module

MeSH Terms

ID	Term
D004522	Educational Status

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided