Survey of Women's Choice of Delivery Before Consulting With Her Obstetrician

Understanding a Woman's Choice of Mode of Delivery Before Initial Consult With Her Obstetrician After Having One Prior Cesarean Section

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.

Study Overview

• Status: Terminated
• Conditions: Pregnancy; Previous Cesarean Section
• Intervention / Treatment: Other: Survey

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from the new obstetrics patients in the University of California, Davis Department of Obstetrics and Gynecology department clinics.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with a prior cesarean section; Survey of women who had a cesarean section with their last pregnancy and no other prior cesarean section deliveries	Other: Survey; Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Maricela Rangel-Garcia, University of California, Davis; Study Director: Mitchell Creinin, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 27, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Pregnancy; Survey; Delivery; Cesarean Section
• Other Study ID Numbers: 477211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No