NCT01092156

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

March 22, 2010

Last Update Submit

September 23, 2023

Conditions

Nipple Pain During Lactation

Keywords

Nipple pain during lactation

Outcome Measures

Primary Outcomes (1)

  • Nipple pain day 3 postpartum

    Day 3 postpartum

Secondary Outcomes (1)

  • Breastfeeding status day 30 postpartum

    Day 30 postpartum

Study Arms (2)

Education on Infant-led latching

ACTIVE COMPARATOR
Behavioral: Education

Standard education

NO INTERVENTION

Interventions

EducationBEHAVIORAL

Education on Infant-led latching

Education on Infant-led latching

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sutter Davis Hospital

Davis, California, 95616, United States

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Caroline J Chantry, M.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Kathryn G Dewey, Ph.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 24, 2010

Study Start

January 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

US(1)