Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination

Breast Feeding Clinical Trial

— IMPAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395168
• Other study ID #: 23-012862
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 246
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Other:
• Combined Newborn and Lactation Visit
See Arm/Group Description

Locations

Country	Name	City	State
United States	Mayo Clinic Health System-Eau Claire Clinic	Eau Claire	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)