- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02213874
The Influence of Trust in the Health Care System on Postpartum Contraceptive Choice
The purpose of this research is to understand the relationship between trust in the health care system and choice of contraception during the postpartum period among pregnant women receiving prenatal care.
Research subjects will complete a questionnaire at enrollment and between delivery and within 5 days of hospital discharge.
A chart review will also be completed to gather use of a birth control method at the six week postpartum visit as well as pertinent medical diagnoses and recorded data such as height, weight, body mass index, and contraceptive plan as documented in the postpartum medical chart.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aims of the proposed research are three-fold:
- To identify whether trust in the health care system is associated with choice of the highest efficacy contraception (intrauterine contraception, implantable contraception, and sterilization) in the immediate postpartum period among pregnant women receiving prenatal care.
- To explore which patient-level factors (sociodemographic, reproductive history, future pregnancy intentions) and provider-level factors (antenatal contraceptive counseling) are associated with choice of the highest efficacy contraception in the immediate postpartum period among pregnant women receiving prenatal care.
- To determine whether trust in the health care system is altered during the receipt of prenatal care or delivery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- MUSC Women's Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant Women receiving prenatal care at Medical University of South Carolina (MUSC)
- Age 18 or older
Exclusion Criteria:
- Greater than 20 weeks gestation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Questionnaire
A questionnaire will be administered during the early stages of prenatal care & again during the postpartum period.
The initial questionnaire will assess trust in the health care system, locus of control, religiosity, health literacy & collect information about demographics, contraceptive & reproductive history, future pregnancy intentions, & baseline knowledge about contraception.
The postpartum questionnaire will repeat questions about future pregnancy & contraception intentions, trust in the health care system, knowledge of contraception and collect new information about characteristics of antenatal contraceptive counseling received including whether a provider recommended a specific method of contraception, the amount of counseling received, & the type of counseling received.
|
A questionnaire will be administered during the early stages of prenatal care & again during the postpartum period.
The initial questionnaire will assess trust in the health care system, locus of control, religiosity, health literacy & collect information about demographics, contraceptive & reproductive history, future pregnancy intentions, & baseline knowledge about contraception.
The postpartum questionnaire will repeat questions about future pregnancy & contraception intentions, trust in the health care system, knowledge of contraception and collect new information about characteristics of antenatal contraceptive counseling received including whether a provider recommended a specific method of contraception, the amount of counseling received, & the type of counseling received.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Choice of long acting contraception (IUD or implant) for postpartum contraception
Time Frame: immediately postpartum
|
Using a questionnaire adminstered immediately postpartum, we will ascertain whether participants indicate plan to use either an IUD or implant for contraception.
We will also measure use of IUD or implant through chart abstraction of their 6 week postpartum visit.
|
immediately postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trust in the health care system
Time Frame: immediately postpartum
|
We will also evaluate trust as an outcome and evaluate whether certain patient-level or antepartum care characteristics predict higher levels of trust.
Trust is measured through a validated scale containing 17 questions measured using a likert scale.
|
immediately postpartum
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Angela Angela Dempsey, MD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Dempsey-Trust Pro 12660
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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