Evaluation of the Reliability, Validity, and Acceptabilit... | NCT00306007

Studies
Evaluation of the Reliability, Validity, and Acceptability of the London Measure of Unplanned Pregnancy in a U.S. Population of Women

NCT00306007

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Jun 25, 2013Estimated

Enrollment

320Actual

Phase

Not provided

Conditions

Unplanned Pregnancy

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

Jun 2013

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

Nov 2005

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Mar 17, 2006

First Submission Date that Met QC Criteria

Mar 21, 2006

First Posted Date

Mar 22, 2006Estimated

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

Jun 23, 2013

Last Update Posted Date

Jun 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 study is to evaluate the reliability, validity, and acceptability of the London Measure of Unplanned Pregnancy (LMUP) in a U.S. population of women. The researchers hypothesize that the LMUP will be acceptable to a U.S. population and will be reliable and valid.

Detailed Description

The concept of "unplanned pregnancy" is used frequently in health research and policy. The majority of tools used to assess unplanned pregnancy planning have not been validated. Recently the London Measure of Unplanned Pregnancy (LMUP) has been developed and validated. The LMUP had been found to be valid and reproducible, but has not been studied outside of the United Kingdom. If we are able to validate this measure in a U.S. population, its use in studies will improve the quality of data about family planning in U.S. women.

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

320Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
English prenatal		English speaking women recruited from the general OB/GYN clinic
Spanish prenatal		Spanish speaking (monolingual) women recruited from the general OB/GYN clinic
English abortion clinic		English speaking women recruited from the abortion clinic
Spanish abortion clinic		Spanish speaking (monolingual) women recruited from the abortion clinic

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women
Basic literacy in English or Spanish needed to participate.

Exclusion Criteria:

Literacy level lower than 11 years of age

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

target population for this study is pregnant women who present to san Francisco General Hospital (SFGH) Women's Options Center (WOC) for abortion and to the Women's Health Center for prenatal care. The population is racially and ethnically diverse, and the majority are financially challenged and have no insurance or Medicaid.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jody Steinauer, MD, MAS	University of California, San Francisco	Principal Investigator
Diane Morof, MD, MSc	University of California, San Francisco	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Francisco General Hospital		San Francisco	California	94110	United States