Measuring Preferences for Childbirth After Cesarean
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|ClinicalTrials.gov Identifier: NCT00267735|
Recruitment Status : Unknown
Verified December 2005 by Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : December 21, 2005
Last Update Posted : September 11, 2006
|Condition or disease||Intervention/treatment|
|Pregnancy||Behavioral: Use of Computerized Decision Aid on Childbirth|
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:
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Measuring Preferences for Childbirth After Cesarean|
|Study Start Date :||January 2006|
- Decisional conflict scores (knowledge of options; clarity about preferences; decisional certainty; conflict) after using decision aid.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267735
|Contact: Karen B Eden, PhD||503 firstname.lastname@example.org|
|Contact: Jeanne-Marie Guise, MD, MPH||503 email@example.com|
|United States, Oregon|
|Oregon Health & Science University Clinics||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Karen B Eden, PhD 503-494-2456 firstname.lastname@example.org|
|Contact: Christina Dahlstrom, BS 503 494-4693 email@example.com|
|Principal Investigator: Karen B Eden, PhD|
|Principal Investigator:||Karen B Eden, PhD||Oregon Health and Science University|