Contraception BehaviorNCT02213874
The Influence of Trust in the Health Care System on Postpartum Contraceptive Choice
A study testing Questionnaire in people with Contraception Behavior and Contraception, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior, Contraception
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2015
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant Women receiving prenatal care at Medical University of South Carolina (MUSC)
- Age 18 or older
Who cannot join
- Greater than 20 weeks gestation
Trial locations and contacts
1 site in 1 country.
United States1 site
MUSC Women's Health
Charleston, South Carolina, 29425
About this study
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.
Read the 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.
- Conditions
- Contraception Behavior, Contraception
- Being tested
- Questionnaire
- Keywords
- Pregnant Women, Women's Health, Contraception, Trust in Health Care
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Other | 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice of long acting contraception (IUD or implant) for postpartum contraception
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.
Measured: immediately postpartum
Secondary outcomes (1)
Trust in the health care system
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.
Measured: immediately postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Angela Dempsey, Medical University of South Carolina
- Investigators
- Angela Angela Dempsey, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213874
- Sponsor's protocol ID
- Dempsey-Trust Pro 12660
- Status last verified
- Apr 2023
- First submitted
- 5 Aug 2014
- Last updated
- 1 May 2023
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Trust in the Health Care System on Postpartum Contraceptive Choice
- ClinicalTrials.gov ID
- NCT02213874
- Acronym / sponsor ID
- Dempsey-Trust Pro 12660
- Conditions
- Contraception Behavior, Contraception
- Keywords
- Pregnant Women, Women's Health, Contraception, Trust in Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Aug 2014 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | Other | Other: QuestionnaireA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant Women receiving prenatal care at Medical University of South Carolina (MUSC)
- Age 18 or older
Key exclusion criteria (1 listed)
- Greater than 20 weeks gestation
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 |
|---|---|---|
| QuestionnaireA 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. | Other | Questionnaire |
Primary outcome
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.
1 secondary outcome
Trust in the health care system
Time frame: immediately postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- 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.
Angela Angela Dempsey, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Contraception Behavior and Contraception, run by Medical University of South Carolina 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 1 May 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Choice of long acting contraception (IUD or implant) for postpartum contraception (time frame: immediately postpartum). 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 1 May 2023.