NCT02010671

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

September 27, 2013

Last Update Submit

May 24, 2017

Conditions

Keywords

PregnancyCesarean SectionSurveyDelivery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Factors that influence participant's opinion of mode of delivery

    Collected at time of study enrollment, typically 4-12 weeks into the subject's pregnancy.

Other Outcomes (1)

  • Trust of information they receive

    Collected at study enrollment, typically 4-12 weeks into the subject's pregnancy.

Study Arms (1)

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

Interventions

SurveyOTHER

Survey

Women with a prior cesarean section

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Pregnant Women
  • years old or older
  • Prior pregnancy with cesarean delivery
  • No prior obstetric physician care during current pregnancy

You may not qualify if:

  • More than one prior cesarean
  • Women who cannot read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Department of Obstetrics and Gynecology

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Maricela Rangel-Garcia

    University of California, Davis

    PRINCIPAL INVESTIGATOR
  • Mitchell Creinin, MD

    University of California, Davis

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2013

First Posted

December 13, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2015

Study Completion

July 1, 2015

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations