PregnancyNCT02010671
Survey of Women's Choice of Delivery Before Consulting With Her Obstetrician
An observational study of Pregnancy and Previous Cesarean Section, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Previous Cesarean Section
- What is being tested?
- Survey
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from the new obstetrics patients in the University of California, Davis Department of Obstetrics and Gynecology department clinics.
Who may be able to join
- Pregnant Women
- 18 years old or older
- Prior pregnancy with cesarean delivery
- No prior obstetric physician care during current pregnancy
Who cannot join
- More than one prior cesarean
- Women who cannot read English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Department of Obstetrics and Gynecology
Sacramento, California, 95817
About this study
Official title: 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.
Read the 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).
- Conditions
- Pregnancy, Previous Cesarean Section
- Being tested
- Survey
- Keywords
- Pregnancy, Cesarean Section, Survey, Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Opinions of mode of delivery as compared to actual mode of delivery
Mode of delivery
Measured: Mode of delivery will be assessed after delivery, average 40 weeks gestational age (7-9 months after enrollment)
Secondary outcomes (1)
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).
Measured: Collected at time of study enrollment, typically 4-12 weeks into the subject's pregnancy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2015
- Study completionJul 2015
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maricela Rangel-Garcia, Principal investigator, University of California, DavisMitchell Creinin, MD, Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010671
- Sponsor's protocol ID
- 477211
- Status last verified
- May 2017
- First submitted
- 27 Sep 2013
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding a Woman's Choice of Mode of Delivery Before Initial Consult With Her Obstetrician After Having One Prior Cesarean Section
- ClinicalTrials.gov ID
- NCT02010671
- Acronym / sponsor ID
- 477211
- Conditions
- Pregnancy, Previous Cesarean Section
- Keywords
- Pregnancy, Cesarean Section, Survey, Delivery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with a prior cesarean section | – | Other: SurveySurvey of women who had a cesarean section with their last pregnancy and no other prior cesarean section deliveries |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the new obstetrics patients in the University of California, Davis Department of Obstetrics and Gynecology department clinics.
Key inclusion criteria (4 listed)
- Pregnant Women
- 18 years old or older
- Prior pregnancy with cesarean delivery
- No prior obstetric physician care during current pregnancy
Key exclusion criteria (2 listed)
- More than one prior cesarean
- Women who cannot read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySurvey | Other | Women with a prior cesarean section |
Primary outcome
Participant Opinions of mode of delivery as compared to actual mode of delivery
Time frame: Mode of delivery will be assessed after delivery, average 40 weeks gestational age (7-9 months after enrollment)
Mode of delivery
1 secondary outcome
Factors that influence participant's opinion of mode of delivery
Time frame: Collected at time of study enrollment, typically 4-12 weeks into the subject's pregnancy.
Results and safety
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maricela Rangel-Garcia principal investigator
University of California, Davis
Mitchell Creinin, MD study director
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Previous Cesarean Section, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Opinions of mode of delivery as compared to actual mode of delivery (time frame: Mode of delivery will be assessed after delivery, average 40 weeks gestational age (7-9 months after enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.