Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination

NCT ID: NCT06395168

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-19

Study Completion Date

2026-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Breast Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Combined Newborn and Lactation Visit

Intervention Type OTHER

See Arm/Group Description

Separate Lactation and Newborn visit

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Combined Newborn and Lactation Visit

See Arm/Group Description

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Melissa A. Thompson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa Thompson, CNP, DNP, APNP

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Linh Tran

Role: CONTACT

715-838-5871

Facility Contacts

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Melissa Thompson, CNP, DNP, APNP

Role: primary

715-838-5025

Related Links

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Other Identifiers

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23-012862

Identifier Type: -

Identifier Source: org_study_id

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