Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination

NCT06395168 | Recruiting

• 1 other identifier: 23-012862
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore whether combining the first post-hospital newborn provider visit and lactation consultation into a single appointment can enhance rates of successful breastfeeding initiation and continuation at predefined intervals (e.g., one week, one month, two months, three months, four months, six months, and 12 months postpartum).

Conditions

Breast Feeding

Outcome Measures

Primary Outcomes (1)

• Difference of breastfeeding rates with a combined lactation/newborn visit versus separate visits.

  Looking for the difference of breastfeeding continuation between the intervention and control group. Hypothesis is higher breastfeeding rates in the combined lactation/newborn visit.

  Duration of the study (expected 1 year)

Study Arms (2)

Combined Lactation and Newborn visit

ACTIVE COMPARATOR

This arm is the intervention where the newborn visit with the pediatric provider is within a lactation consultant visit for a breastfeeding newborn and mother.

Other: Combined Newborn and Lactation Visit

Separate Lactation and Newborn visit

NO INTERVENTION

This is current state of care in which a newborn visit is separate and apart from a Lactation Consultation.

Interventions

Combined Newborn and Lactation Visit OTHER

See Arm/Group Description

Combined Lactation and Newborn visit

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers aged greater than or equal to 18 years.
• Mothers who are able to provide informed consent for participation in this study.
• Mothers registered as patients at Mayo Clinic Health System Northwest Wisconsin.
• Mothers who have given birth within the past four days prior to enrollment into this study.
• Mothers who intend to breastfeed their newborns.
• Mothers who are willing and able to participate in this study.
• Mothers who are able to communicate in English.
• Mothers with the ability to connect to the internet and complete electronic data collection.

You may not qualify if:

• Mothers who are unable or unwilling to provide informed consent for participation in this study.
• Mothers less than 18 years of age.
• Mothers unable to complete study procedures or follow-up visits.
• Mothers with medical complications that could interfere with breastfeeding (e.g., breast reduction).
• Mothers who have no intention to breastfeed their newborns.
• Mothers who are unwilling to follow up with lactation.
• Infants who have already had their first postpartum outpatient provider visit.
• Pre-term infants (less than 37 weeks).
• Special care admission greater than two days.
• Length of stay or anticipated LOS greater than four days.
• Transfer to an outside facility.
• Inability to communicate in English.
• When slots are no longer available.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54703, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Melissa Thompson, CNP, DNP, APNP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linh Tran

CONTACT

715-838-5871

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)