Clinical trial NCT02010671: Survey of Women's Choice of Delivery Before Consulting With Her Obstetrician
Official title: Understanding a Woman's Choice of Mode of Delivery Before Initial Consult With Her Obstetrician After Having One Prior Cesarean Section
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Previous Cesarean Section
Keywords: Pregnancy
Cesarean Section
Survey
Delivery
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Participant Opinions of mode of delivery as compared to actual mode of delivery
timeFrame: Mode of delivery will be assessed after delivery, average 40 weeks gestational age (7-9 months after enrollment)
Secondary outcomes:
measure: Factors that influence participant's opinion of mode of delivery
timeFrame: Collected at time of study enrollment, typically 4-12 weeks into the subject's pregnancy.
Other outcomes:
measure: Trust of information they receive
timeFrame: Collected at study enrollment, typically 4-12 weeks into the subject's pregnancy.
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Department of Obstetrics and Gynecology
state: California
Study officials:
affiliation: University of California, Davis
name: Maricela Rangel-Garcia
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Mitchell Creinin, MD
role: STUDY_DIRECTOR
References: