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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02010671
Other study ID # 477211
Secondary ID
Status Terminated
Phase N/A
First received September 27, 2013
Last updated May 24, 2017
Start date September 2013
Est. completion date July 2015

Study information

Verified date May 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We are surveying women who have had a previous cesarean section at the time of entry into prenatal care for their next pregnancy about their thoughts related to a trial of labor after cesarean (TOLAC) or repeat c-section.


Description:

This is a survey for women who have had a previous cesarean section, also known as a c-section, with their last pregnancy. The study is looking at what factors and people may influence the decisions women make about their birthing plan after they have had a previous c-section. If they qualify, women will be asked to complete a brief survey at their initial Ob/Gyn appointment before they see their Ob doctor. In order to qualify, women must:

- Be pregnant

- Have not seen an obstetrician for this pregnancy

- Be at least 18 years old

- Be able to read English

- Have had a prior pregnancy delivered by c-section

- Only had one prior c-section

- The c-section must have been the last pregnancy before this one

Questions that will be asked include:

- Demographic information (examples: age, race/ethnicity)

- Pregnancy information

- Delivery questions

- Factors that may influence her birthing plan

Participants will also be asked if the study staff can follow up after her delivery to see what kind of delivery she had (vaginal or c-section).


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date July 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pregnant Women

- 18 years old or older

- Prior pregnancy with cesarean delivery

- No prior obstetric physician care during current pregnancy

Exclusion Criteria:

- More than one prior cesarean

- Women who cannot read English

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
Survey

Locations

Country Name City State
United States University of California, Davis Department of Obstetrics and Gynecology Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Trust of information they receive Participants will be asked if they trust the information that they receive from influencing factors, such as significant others, clinicians, family, friends, or other. Collected at study enrollment, typically 4-12 weeks into the subject's pregnancy.
Primary Participant Opinions of mode of delivery as compared to actual mode of delivery Mode of delivery Mode of delivery will be assessed after delivery, average 40 weeks gestational age (7-9 months after enrollment)
Secondary Factors that influence participant's opinion of mode of delivery Participants will be asked what influences their opinions of mode of delivery, such as significant other, clinicians, family, friends, or others. They will also be asked how much these factors may influence their decisions (high influence, some influence, no influence). Collected at time of study enrollment, typically 4-12 weeks into the subject's pregnancy.
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