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Completed

NCT Number: NCT00267735

Measuring Preferences for Childbirth After Cesarean

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University Clinics

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of Computerized Decision Aid on Childbirth

Behavioral

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2005
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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