NCT00267735

Brief Summary

The objective of this proposed 18-month exploratory research study is to help pregnant women weigh risks and benefits in a childbirth decision using the Preferences-Assessment Computer Module. Our hypothesis is that, after using this computer module, women will be more aware of the potential risks and benefits of VBAC and of elective repeat cesarean and will have greater clarity about their preferences related to these risks and benefits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

8.8 years

First QC Date

December 20, 2005

Last Update Submit

December 9, 2019

Conditions

Pregnancy

Keywords

pregnancyrepeat cesareanvaginal birth after cesarean

Outcome Measures

Primary Outcomes (1)

  • Decisional conflict scores (knowledge of options; clarity about preferences; decisional certainty; conflict) after using decision aid.

Study Arms (2)

Module 1 Only

NO INTERVENTION

Modules 1, 2, and 3

EXPERIMENTAL
Behavioral: Use of Computerized Decision Aid on Childbirth

Interventions

Use of Computerized Decision Aid on ChildbirthBEHAVIORAL
Modules 1, 2, and 3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or older
  • pregnant
  • candidate for VBAC
  • singleton pregnancy
  • one prior cesarean
  • with a non-vertical uterine scar
  • English or Spanish speaking

You may not qualify if:

  • more than one prior cesarean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University Clinics

Portland, Oregon, 97239, United States

Location

Study Officials

  • Karen B Eden, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 21, 2005

Study Start

January 1, 2006

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations

US(1)