Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination (IMPAC)

June 19, 2026 updated by: Melissa A. Thompson, Mayo Clinic

IMPAC: Integrated Maternal Postpartum Appointment Combination in Mayo Clinic Health System Northwest Wisconsin

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This interventional, comparative effectiveness study investigates the impact of integrating the first newborn outpatient provider and lactation consultant visits, potentially reducing appointments for new mothers while ensuring early lactation support. The outcomes, including breastfeeding continuation rates and maternal satisfaction, will be measured against the conventional separate visit model. The ultimate goal is to prolong breastfeeding duration, enhance care quality, improve efficiency, and enrich patient experience.

Study Type

Interventional

Enrollment (Estimated)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54703
        • Mayo Clinic Health System-Eau Claire Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Combined Lactation and Newborn visit
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
See Arm/Group Description
No Intervention: Separate Lactation and Newborn visit
This is current state of care in which a newborn visit is separate and apart from a Lactation Consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of breastfeeding rates with a combined lactation/newborn visit versus separate visits.
Time Frame: Duration of the study (expected 1 year)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Melissa Thompson, CNP, DNP, APNP, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-012862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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