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Measuring Preferences for Childbirth After Cesarean

Measuring Preferences for Childbirth After Cesarean

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00267735
Enrollment
131
Registered
2005-12-21
Start date
2006-01-31
Completion date
2014-10-31
Last updated
2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

pregnancy, repeat cesarean, vaginal birth after cesarean

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.

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.

Interventions

BEHAVIORALUse of Computerized Decision Aid on Childbirth

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026