Skip to main content
OpenTrials
Completed

NCT Number: NCT03774797

Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation

The objective of this study is to test and disseminate tools that drive successful immediate postpartum Long-Acting Reversible Contraception (LARC) implementation. The long-term goal is to reduce unintended pregnancy soon after childbirth by increasing access to immediate postpartum LARC for women who desire it.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

About this study

Based on previous work, the investigators have generated a toolkit to guide the integration of immediate postpartum LARC services into widespread clinical practice. In the proposed work, this toolkit will be used to initiate immediate postpartum LARC services in a single site with low baseline immediate postpartum LARC uptake (Michigan Medicine). The investigators will conduct a feasibility study using mixed methods to assess acceptability and appropriateness of toolkit items; patient experience of care; immediate postpartum LARC utilization rate; and prenatal contraceptive counseling rate.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female (patients)
  • Pregnant (patients)
  • Receiving obstetrical care at Michigan Medicine (patients)
  • L&D provider at Michigan Medicine (providers)

Exclusion criteria

  • non-English speaking
  • unable to provide informed consent

Treatment and study plan

Implementation Toolkit

Other

Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.

Primary outcomes

  1. Patient experience of care

    Time frame: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care

    Patient online surveys about their experience of care during prenatal visits, hospital stay, or postpartum office visit

  2. Acceptability of care process - patients

    Time frame: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care

    Online survey assessing experience of care, acceptability and appropriateness of implementation tools

  3. Appropriateness of care process - patients

    Time frame: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care

    Online survey assessing experience of care, acceptability and appropriateness of implementation tools

  4. Acceptability of implementation process - study site maternity care providers

    Time frame: Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care

    Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools

  5. Appropriateness of implementation process - study site maternity care providers

    Time frame: Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care

    Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools

Secondary outcomes

  1. Acceptability of implementation toolkit items - patients

    Time frame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care

    30-minute follow-up in-person interview of subgroup of patients who completed surveys

  2. Appropriateness of implementation toolkit items - patients

    Time frame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care

    30-minute follow-up in-person interview of subgroup of patients who completed surveys

  3. Acceptability of implementation toolkit items - providers

    Time frame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care

    30-minute follow-up in-person interview of subgroup of providers who completed survey

  4. Appropriateness of implementation toolkit items - providers

    Time frame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care

    30-minute follow-up in-person interview of subgroup of providers who completed survey

  5. Perinatal contraceptive counseling rate

    Time frame: Measured monthly, up to 24 months after toolkit implementation

    Proportion of delivered patients with documentation of prenatal counseling about postpartum contraception

  6. Immediate postpartum LARC provision rate

    Time frame: Measured monthly, up to 24 months after toolkit implementation

    Proportion of delivered patients with documentation of preference for immediate postpartum LARC who receive a LARC device

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Immediate Postpartum LARC Implementation: Pilot Study at Michigan Medicine

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2018
Registry last updated
Feb 12, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.