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Active, Not Recruiting

NCT Number: NCT06395168

Mayo Clinic Health System Northwest Wisconsin Integrated Maternal Postpartum Appointment Combination

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Combined Newborn and Lactation Visit

Other

See Arm/Group Description

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: IMPAC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 2, 2024
Registry last updated
Jun 24, 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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