Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03510260 |
| Other study ID # |
18-0063 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 8, 2018 |
| Est. completion date |
August 1, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
The University of Texas Medical Branch, Galveston |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
· The target population for our study is women who present in their last clinic visit before
delivery and are scheduled for an elective cesarean section. In that visit, the provider will
notify the research team in order for the subject to be screened for the study. If the
subject consents to participation, written informed consent will be obtained by
person-to-person contact. The PI, study coordinator, or a collaborator will be responsible
for the informed consent. After in-formed consent is obtained, the patient will be randomized
to the following study groups:
The control group will undergo regular consenting only.
Study group I (e-confirmed consent only) will receive an electronic invitation to complete
the consent process electronically and will proceed through the Confirmed Consent system
prior to arrival to labor and delivery on day of surgery, which is the routine patient flow
at this time. After completion of the survey, the subject will sign the regular paper consent
for the procedure as standard in our institution.
The study group II will undergo the same intervention as group II but the COMRADE survey
questionnaire will be obtained by phone or in person after the completion of the paper
consent form.
Description:
4.1 Screening, Recruitment, and Consenting:
- Under the direction of the PI, trained research staff will be available 24/7 to screen
and con-sent patients according to study protocol. Patients will be enrolled at the time
a decision for planned repeat cesarean after VBAC counseling is made in clinic.
- After informed consent is obtained, the patient will be randomized to the study group or
the control group. A screening log will be used to track all patients approached for the
study. Women will only be randomized in clinic.
- Recruitment: We will recruit all pregnant patient's decision was made for scheduled
cesarean after VBAC counseling made by their managing clinical team who do not meet any
of the ex-clusion criteria listed below. Once the inclusion criteria for our study are
met, the primary team will inform the patient about the study and ask her authorization
to contact one of the study personnel.
- Consenting process: Written consent will be obtained by direct person-to-person contact.
The principal investigator, study coordinator, or a collaborator will be responsible for
the informed consent. Non-English-speaking subjects are anticipated to be part of the
study population and informed consent will be provided in their primary language.
The data collected will not be used for clinical diagnosis or treatment purposes.
Subjects will be reassured that participation in the study is voluntary and will not
interfere with diag-nose or treatment of her condition.
The subjects will receive the same care and expertise as any other patient treated in our
institution.
4.2. Randomization and Masking A confidential computer-generated simple randomization scheme
(using STATA 14, Dallas, TX) will be prepared and provided on an ongoing basis to our study
coordinator. A randomization log with group assignment, subject name, and medical record
number will be used to track the randomization process.
The subject will be included in the analysis by intent-to-treat once the randomization
assignment has been made.
4.3. Interventions The control group will undergo regular consenting only. At our unit
consent for an elective ce-sarean delivery occurs in the same day of surgery, few hours
before the procedure in a private room in labor and delivery while awaiting surgery. The
COMRADE questionnaire (our primary outcome) will be obtained after the completion of the
paper consent form.
Study group I (e-confirmed consent only) will receive an electronic invitation to complete
the consent process electronically and will proceed through the Confirmed Consent system
prior to arrival to labor and delivery on day of surgery, which is the routine patient flow
at this time. The COMRADE questionnaire (our primary outcome) will be obtained prior to the
initiation of the traditional consent (as in control group) before the completion of the
paper consent form, in order to assess satisfaction and understanding of the e-confirmed
consenting process completed before the procedure. After completion of the survey, the
subject will sign the regular paper consent for the procedure as standard in our institution.
The study group II will undergo the same intervention as group II but the COMRADE survey
questionnaire will be obtained after the paper consent is obtained in order to assess whether
both methods combined together improve the subjects' satisfaction of the consenting methods
and better understanding of the surgical procedure.
4.4. Survey Collection This is our primary outcome. Before the subject has the procedure, our
research staff will be collecting a survey assessing understanding of procedure and
satisfaction, please see attached survey with appli-cation. This survey will be obtained
according to the interventions detailed in sections 3 & 4.3
