ContraceptionNCT02438800
Video Counseling for Effective Postpartum Contraception
A study testing LARC First Video in people with Contraception, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a randomized clinical trial to evaluate if the addition of long-acting reversible contraception (LARC) focused video-counseling during prenatal care increases uptake of postpartum LARC. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- LARC First Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Oct 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- woman presenting for routine prenatal care visit at University of North Carolina (UNC) Resident Continuity Clinic
- least 18 years old
- fluent in English
- able to read to a third-grade reading level
- not planning sterilization for postpartum contraception
- at least 28 weeks gestation at time of enrollment
Who cannot join
- those who do not meet the previously outlined inclusion criteria
- those who are unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Women's Hospital
Chapel Hill, North Carolina, 27599
About this study
Official title: Video Counseling for Effective Postpartum Contraception: a Randomized Clinical Trial
This is a randomized clinical trial to evaluate if the addition of long-acting reversible contraception (LARC) focused video-counseling during prenatal care increases uptake of postpartum LARC.
Read the detailed description
Eligible participants will be identified in the prenatal period and will be randomized to one of two groups. The control group will receive the standard of care contraceptive counseling during prenatal counseling. The intervention group will also receive the standard of care contraceptive counseling during prenatal care, but will also watch an evidence-based,12 minute LARC First video created by the CHOICE project which provides information on different contraceptive methods. All participants will receive information regarding access to free LARC methods in the postpartum period. All participants will be called at 12 weeks postpartum. Independent of randomization arm, they will all undergo a 5-minute survey by phone about contraceptive method choice and use.
- Conditions
- Contraception
- Being tested
- LARC First Video
- Keywords
- Postpartum Period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARC First VideoBehavioural
LARC First is an evidence-based, 12-minute video developed by the CHOICE project that features women of all racial and ethnic backgrounds describing LARC methods of contraception in simple, understandable language with summary text when appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Standard Counseling | No intervention | Women in this arm will receive standard contraceptive counseling routinely provided during prenatal care. All participants will receive information regarding access to free LARC methods in the postpartum period. |
| Video Counseling | Experimental | Women in this arm will receive LARC First video-based contraceptive counseling in addition to standard contraceptive counseling routinely provided during prenatal care. All participants will receive information regarding access to free LARC methods in the postpartum period. Receives: Behavioral: LARC First Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women who received an intrauterine device (IUD) or implant by 12 weeks postpartum
Measured: 12 weeks postpartum
Secondary outcomes (3)
Proportion of women using any contraceptive method at 12 weeks postpartum
Measured: 12 weeks postpartum
Proportion of women who attended a postpartum visit
Measured: 12 weeks postpartum
Proportion of women answering agree or strongly agree to the following statement "I would recommend birth control counseling by video to a friend."
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Morse, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438800
- Sponsor's protocol ID
- 15-0665
- Status last verified
- May 2017
- First submitted
- 6 May 2015
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Counseling for Effective Postpartum Contraception: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02438800
- Acronym / sponsor ID
- 15-0665
- Conditions
- Contraception
- Keywords
- Postpartum Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 May 2015 (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.
This is a randomized clinical trial to evaluate if the addition of long-acting reversible contraception (LARC) focused video-counseling during prenatal care increases uptake of postpartum LARC.
Detailed description
Eligible participants will be identified in the prenatal period and will be randomized to one of two groups. The control group will receive the standard of care contraceptive counseling during prenatal counseling. The intervention group will also receive the standard of care contraceptive counseling during prenatal care, but will also watch an evidence-based,12 minute LARC First video created by the CHOICE project which provides information on different contraceptive methods. All participants will receive information regarding access to free LARC methods in the postpartum period. All participants will be called at 12 weeks postpartum. Independent of randomization arm, they will all undergo a 5-minute survey by phone about contraceptive method choice and use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Counseling | No intervention | –Women in this arm will receive standard contraceptive counseling routinely provided during prenatal care. All participants will receive information regarding access to free LARC methods in the postpartum period. |
| Video Counseling | Experimental | Behavioral: LARC First VideoWomen in this arm will receive LARC First video-based contraceptive counseling in addition to standard contraceptive counseling routinely provided during prenatal care. All participants will receive information regarding access to free LARC methods in the postpartum period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- woman presenting for routine prenatal care visit at University of North Carolina (UNC) Resident Continuity Clinic
- least 18 years old
- fluent in English
- able to read to a third-grade reading level
- not planning sterilization for postpartum contraception
Key exclusion criteria (2 listed)
- those who do not meet the previously outlined inclusion criteria
- those who are unable to provide informed consent.
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 |
|---|---|---|
| LARC First VideoLARC First is an evidence-based, 12-minute video developed by the CHOICE project that features women of all racial and ethnic backgrounds describing LARC methods of contraception in simple, understandable language with summary text when appropriate. | Behavioural | Video Counseling |
Primary outcome
Number of women who received an intrauterine device (IUD) or implant by 12 weeks postpartum
Time frame: 12 weeks postpartum
3 secondary outcomes
Proportion of women using any contraceptive method at 12 weeks postpartum
Time frame: 12 weeks postpartum
Proportion of women who attended a postpartum visit
Time frame: 12 weeks postpartum
Proportion of women answering agree or strongly agree to the following statement "I would recommend birth control counseling by video to a friend."
Time frame: Baseline
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 18 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jessica Morse, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LARC First Video in people with Contraception, run by University of North Carolina, Chapel Hill 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 6 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: finished, as of the sponsor's last update on 18 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 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?
Number of women who received an intrauterine device (IUD) or implant by 12 weeks postpartum (time frame: 12 weeks 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 18 May 2017.