Abo Follow-up Study | NCT03243513

Studies
Abo Follow-up Study

NCT03243513

Sponsor

University of New Mexico

Status

Terminated

Last Update Posted

Jan 12, 2024Actual

Enrollment

1,600Actual

Phase

Not provided

Conditions

Pregnancy Termination

Interventions

Retrospective Chart Review

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI has confirmed that this is not a clinical trial and was entered in error in the system.

Expanded Access Info

Start Date

Aug 4, 2017Actual

Primary Completion Date

Feb 28, 2020Actual

Completion Date

Feb 28, 2020Actual

First Submitted Date

Aug 4, 2017

First Submission Date that Met QC Criteria

Aug 4, 2017

First Posted Date

Aug 9, 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

Jan 10, 2024

Last Update Posted Date

Jan 12, 2024Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the project is to identify an efficient and effective policy or procedure for identifying complications from surgical abortions through follow-up phone calls.

Detailed Description

The aim of the project is to identify an efficient and effective policy or procedure for identifying complications from surgical abortions through follow-up phone calls. Key questions include, what is our complication-detection rate from these phone calls? How many patients are contacted? How many attempts are made and how much effort is expended by staff in routine follow-up practices? Additionally, the research would attempt to answer the question, is there any way to predict problems or complications? This study will help to determine if excessive resources and time are being expended on follow-up phone method to detect complications.

This study will consist of a retrospective chart review identifying the outcome of follow-up phone calls after an induced abortion.

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

1,600Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Retrospective Chart Review	Other	There is no intervention in this research. This research project is a retrospective chart review.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Follow-up Phone Calls	Key questions include, what is our complication-detection rate from these phone calls? How many patients are contacted? How many attempts are made and how much effort is expended by staff in routine follow-up practices?	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Reproductive-aged women
women who have had an induced abortion, and are contacted by a clinical nurse for a follow-up phone call.

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

De-identified charts of women who have had an induced abortion and are contacted by a nurse for a follow-up phone call.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

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

We do not plan on sharing IPD at this time

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided