Measuring Preferences for Childbirth After Cesarean

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00267735
First received: December 20, 2005
Last updated: September 8, 2006
Last verified: December 2005
  Purpose

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.


Condition Intervention
Pregnancy
Behavioral: Use of Computerized Decision Aid on Childbirth

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Measuring Preferences for Childbirth After Cesarean

Further study details as provided by Oregon Health and Science University:

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

Estimated Enrollment: 120
Study Start Date: January 2006
Detailed Description:

As cesarean birth rates continue to climb, the number of women (currently about 420,000 annually) facing the decision of whether to have a repeat cesarean or to attempt a vaginal birth after cesarean (VBAC) will also increase. 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 developed by the principal investigator. The long-term objective of the proposed research is to understand and improve the decision-making process of these women by creating a computerized childbirth decision aid. Such decision aids provide value when the decision is complex, when the outcome is uncertain, and when people vary in how they prioritize preferences; childbirth decisions for women with a prior cesarean meet all these criteria.

No study to date quantifies how women weigh the complexities of various considerations—medical and otherwise—in the delivery decision. The proposed research is significant, therefore, in that it will provide a much-needed method to help women prioritize and weigh their preferences related to childbirth decisions. More broadly, it responds to the recent NIH and AHRQ initiatives to promote the development of computerized decision aids to improve the quality of medical decisions.

A new investigator will lead a well-qualified, multi-disciplined team that has expertise in decision analysis, obstetric medicine, and research methodology in pursuit of the following specific aims:

  1. To validate a precise method to measure childbirth preferences. During the initial phase of this study, we will verify the accuracy of the Preferences Assessment Computer Module, measure internal consistency and assess content validity in a cross-sectional study.
  2. To test whether women who use the Preferences Assessment Computer Module will have increased clarity about their preferences—and about the implication of those preferences—in comparison to women in a control group. We will conduct a randomized controlled trial of pregnant women with a prior cesarean.

This Preferences Assessment Computer Module is appropriate to address not only VBAC decisions, but also decisions related to elective cesareans and induction. In short, the proposed research will advance the field by improving the quality of the decision-making process for childbirth.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • more than one prior cesarean
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267735

Contacts
Contact: Karen B Eden, PhD 503 494-2456 edenk@ohsu.edu
Contact: Jeanne-Marie Guise, MD, MPH 503 494-1602 guisej@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Clinics Recruiting
Portland, Oregon, United States, 97239
Contact: Karen B Eden, PhD    503-494-2456    edenk@ohsu.edu   
Contact: Christina Dahlstrom, BS    503 494-4693    dahlstrc@ohsu.edu   
Principal Investigator: Karen B Eden, PhD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Karen B Eden, PhD Oregon Health and Science University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00267735     History of Changes
Other Study ID Numbers: 1R03 HS 13959-01A1
Study First Received: December 20, 2005
Last Updated: September 8, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
pregnancy
repeat cesarean
vaginal birth after cesarean

ClinicalTrials.gov processed this record on October 21, 2014