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NCT Number: NCT07560553

Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Faculty Medical Offices

Loma Linda, California, 92354-3619, United States

Location status: Recruiting

Location contact

Elaine Hart, M.D.

CONTACT

[email protected]

909-558-2806 ext. 15505

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastfeeding Education

Behavioral

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 will also be administered.

Primary outcomes

  1. 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.

    Subjects will complete a Qualtrics survey of 2 questions administered via text message, to determine breastfeeding exclusivity. This survey will be calculated on a Likert scale 0-100. A percentage of 100% will determine exclusive breastfeeding. A percentage of 70-90% represents intermittent breastfeeding. A percentage of less than 70% represents non-exclusive breastfeeding.

Secondary outcomes

  1. Breastfeeding education pre and post self-efficacy scores of medical students

    Time frame: Change between baseline through study completion, an average of 1 year.

    Assessment of medical student proficiency in breastfeeding management and patient care will be measured using a 25-item multiple-choice questionnaire. The survey evaluates core competencies before and after a structured educational intervention, including the Institute for the Advancement of Breastfeeding and Lactation Education (IABLE) course and a supplemental PowerPoint presentation given by Dr. Elaine Hart. Each question is worth one point, with total scores ranging from 0 to 25; a higher score indicates an increase in breastfeeding knowledge and management competency.

  2. Maternal Satisfaction with Antenatal Breastfeeding Support and Knowledge, Motivation, and Confidence.

    Time frame: Change between 1st trimester and 6 weeks postpartum.

    Assessment of maternal satisfaction with antenatal breastfeeding support, knowledge, motivation, and confidence will be measured using a 13-item questionnaire. The instrument utilizes a combination of 5-point Likert scales to assess self-efficacy and motivation, as well as objective multiple-choice questions to evaluate understanding of breastfeeding benefits, infant output, and clinical management. Knowledge-based items are scored with one point for each correct response, while Likert-scale items are recorded by their selected numerical value (1-5). A higher total composite score represents a longitudinal increase in breastfeeding knowledge, confidence, and motivation from baseline (pre-enrollment) to the 6-week postpartum follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Elaine Hart, M.D.

CONTACT

[email protected]

(909) 558-2806 ext. 15505

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Acronym: iLATCH

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 1, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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