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	Behavior: Use of Computerized Decision Aid on Childbirth

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

Primary Outcomes: Decisional conflict scores (knowledge of options; clarity about preferences; decisional certainty; conflict) after using decision aid.
Expected Total Enrollment:  120

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00267735

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

Oregon
      Oregon Health & Science University Clinics, Portland,  Oregon,  97239,  United States

Study chairs or principal investigators

Karen B Eden, PhD,  Principal Investigator,  Oregon Health and Science University   

Study ID Numbers:  1R03 HS 13959-01A1
Last Updated:  December 20, 2005
Record first received:  December 20, 2005
ClinicalTrials.gov Identifier:  NCT00267735
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10