Evaluation of Immediate Postpartum LARC Implementation Pr... | NCT03118726

Studies
Evaluation of Immediate Postpartum LARC Implementation Programs

NCT03118726

Sponsor

University of New Mexico

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Post Partum Contraception

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 13, 2017Actual

Primary Completion Date

May 31, 2018Actual

Completion Date

May 31, 2019Actual

First Submitted Date

Apr 12, 2017

First Submission Date that Met QC Criteria

Apr 17, 2017

First Posted Date

Apr 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2019

Last Update Posted Date

Aug 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will engage hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. All hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be eligible to participate in the NPMC program evaluation. The study will evaluate the components of this implementation program at several New Mexico hospitals using a stepped wedge design,with components being introduced to each hospital one at a time

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NM Perinatal Collaborative		Hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Baseline immediate postpartum LARC Implementation	To determine baseline immediate postpartum LARC implementation in various rural New Mexico hospitals.	April 2017-December 2018

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospital staff: Important individuals at New Mexico hospitals planning to implement immediate postpartum LARC programs, with an emphasis on diversity of administrative perspectives.
If more than 4 potential participants are identified at one institution, additional participants may be included if their participation in the study is likely to contribute additional information (e.g. job title or background is different from other study participants)

Exclusion Criteria:

- Inability to speak and read English proficiently

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. All hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be eligible to participate in the NPMC program evaluation. The study will evaluate the components of this implementation program at several New Mexico hospitals using a stepped wedge design, with components being introduced to each hospital one at a time.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Lisa Hofler, MD, MBA, MPH	University of New Mexico	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of New Mexico		Albuquerque	New Mexico	87131	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided