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Recruiting NCT07560553

Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers

No phase Interventional Pregnancy Related Breast Feeding, Exclusive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breastfeeding Education.
Who it may be relevant to
Registry conditions: Pregnancy Related, Breast Feeding, Exclusive. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers: Randomized Control Trial

Overview

The purpose of this study is to increase the rate of exclusive breastfeeding at 6 weeks postpartum in the Inland Empire by addressing inadequate antenatal breastfeeding education for patients.

Detailed description

A total of 196 participants will be enrolled and randomized into two groups: an experimental cohort that receives supplemental breastfeeding education during three of their scheduled prenatal visits, and a control group that continues with standard prenatal care alone. Medical students will undergo lactation counselor training to be prepared to visit and educate patients. Both arms of the study will take a pre-survey at the first visit and a post-survey at 6 weeks postpartum to evaluate breastfeeding knowledge, confidence, and motivation. Medical students will also take a survey pre-training and post-study to evaluate growth in breastfeeding education.

Interventions

  • Behavioral Breastfeeding Education
    First meeting will include a pre-test and will go over risks, benefits, and goals for breastfeeding for the mother, baby and family. Second meeting will go over barriers to breastfeeding and the difference between formula and breastmilk. Third visit will include a post-test and go over misconceptions of breastfeeding and the optimal frequency to breastfeed their newborn. Appropriate flyers will be administered at each visit. Congratulatory \& supportive text at birth and 6-week follow up survey

Primary outcome measures

  • Prevalence of Exclusive Breastfeeding at 6 Weeks Postpartum. [Time frame: Change between baseline (time of newborn's first feeding) and 6 week post-partum visit.]
Secondary outcome measures (2)
  • Breastfeeding education pre and post self-efficacy scores of medical students [Time frame: Change between baseline through study completion, an average of 1 year.]
  • Maternal Satisfaction with Antenatal Breastfeeding Support and Knowledge, Motivation, and Confidence. [Time frame: Change between 1st trimester and 6 weeks postpartum.]

Eligibility criteria

Inclusion criteria

  • Nulliparous mothers
  • Multiparous mothers who did not breastfeed previous children or breastfed previous children for less than 6 months

Exclusion criteria

  • Mothers planning to use formula
  • Multiparous mothers who previously breastfed for more than 6 months
  • Mothers with HIV
  • Mothers with a history of breast reduction surgery
  • Infants with major birth defects that may impede growth or feeding, such as cleft lip and/or palate, cardiac defects, and gastrointestinal defects

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Loma Linda University Faculty Medical Offices — Loma Linda

Identifiers

NCT: NCT07560553 · 5260056

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗