Contraceptive UsageNCT03400449
Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization
A study testing Video counseling and Conversational counseling in people with Contraceptive Usage and Contraception Behavior, run by Oregon Health and Science University at 2 sites in Colombia.
Trial summary
A randomized trial comparing LARC uptake and satisfaction after either video or conversational-based contraceptive counseling for pregnant women in labor. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage, Contraception Behavior
- What is being tested?
- Video counseling and Conversational counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesColombia
- Study dates
- 28 Apr 2015to 7 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Live pregnancy >20 weeks gestation
- Admission to maternity ward for labor
- Age >14
Who cannot join
- Pain >=8 on Wong-Baker FACES pain scale
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Maternidad Rafael Calvo
Cartagena
Metrosalud Manrique
Medellín
About this study
Official title: Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization: The COMSE Randomized Trial
A randomized trial comparing LARC uptake and satisfaction after either video or conversational-based contraceptive counseling for pregnant women in labor.
Read the detailed description
This was a multi-center randomized, controlled trial examining contraceptive counseling in the setting of long-acting reversible contraception (LARC) uptake and immediate provision. At two urban public hospitals with large adolescent populations, participants were randomized to a structured, in-person conversation with a trained counselor or a 14-minute video providing the same information. Both participant groups were provided written materials and both had the opportunity to ask questions of the counselor. The total time to complete counseling was measured, as well as participant satisfaction, pre- and post-intervention contraceptive knowledge, and intended postpartum contraceptive method.
- Conditions
- Contraceptive Usage, Contraception Behavior
- Being tested
- Video counseling, Conversational counseling
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video counselingOther
Video counseling
Conversational counselingOther
Conversational counseling
| Study group | Role | What they receive |
|---|---|---|
| Video counseling | Active comparator | The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end. Receives: Other: Video counseling |
| Conversational counseling | Active comparator | The conversation group participated in a structured, face-to-face conversation with a trained counselor. Receives: Other: Conversational counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Counseling Time
Duration of counseling in minutes (from initiation of counseling to conclusion of all questions answered.) The clock was not stopped for breaks, which were allowed as needed.
Measured: Immediately following the intervention, an average of less than 30 minutes
Secondary outcomes (2)
Knowledge Scores
Mean total correct answer (score) to 7 multiple-choice contraceptive knowledge questions. Total possible score is 0-7, with 7 representing 100% correct answers. Score measured after completion of the knowledge questionnaire, on average less than one hour, before (pre) and after (post) counseling.
Measured: One hour
Number of Participants Initiating Postpartum LARC Uptake
Number of participants initiating long-acting reversible contraception (LARC - intrauterine device (IUD) or implant) prior to hospital discharge.
Measured: Assessed at the time of hospital discharge, on average less than 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start28 Apr 2015
- Primary completion7 Aug 2016
- Study completion7 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups randomized to counseling type.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Antioquia
- Responsible party
- Principal investigator, Maureen Baldwin, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400449
- Sponsor's protocol ID
- 11331b
- Status last verified
- Oct 2019
- First submitted
- 20 Dec 2017
- Last updated
- 13 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual sites hold the paper data under monitoring plan through their site Institutional Review Board (IRB - University de Antioquia). They entered de-identified data electronically into REDCap for our use for analysis. We have shared aggregate analysis with the individual sites.
Publications
Hersh AR, Munoz LF, Rincon M, Alvarez C, Tolosa JE, Moreno DJ, Rubio M, Vargas JC, Edna F, Taborda N, Baldwin MK. Video compared to conversational contraceptive counseling during labor and maternity hospitalization in Colombia: A randomized trial. Contraception. 2018 Sep;98(3):210-214. doi: 10.1016/j.contraception.2018.05.004. Epub 2018 May 9.
PubMed 29752923
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization: The COMSE Randomized Trial
- ClinicalTrials.gov ID
- NCT03400449
- Acronym / sponsor ID
- 11331b
- Conditions
- Contraceptive Usage, Contraception Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Universidad de Antioquia
- Study start
- 28 Apr 2015 (actual)
- Primary completion
- 7 Aug 2016 (actual)
- Study completion
- 7 Aug 2016 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized trial comparing LARC uptake and satisfaction after either video or conversational-based contraceptive counseling for pregnant women in labor.
Detailed description
This was a multi-center randomized, controlled trial examining contraceptive counseling in the setting of long-acting reversible contraception (LARC) uptake and immediate provision. At two urban public hospitals with large adolescent populations, participants were randomized to a structured, in-person conversation with a trained counselor or a 14-minute video providing the same information. Both participant groups were provided written materials and both had the opportunity to ask questions of the counselor. The total time to complete counseling was measured, as well as participant satisfaction, pre- and post-intervention contraceptive knowledge, and intended postpartum contraceptive method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups randomized to counseling type.
| Arm | Type | Receives |
|---|---|---|
| Video counseling | Active comparator | Other: Video counselingThe video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end. |
| Conversational counseling | Active comparator | Other: Conversational counselingThe conversation group participated in a structured, face-to-face conversation with a trained counselor. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Live pregnancy >20 weeks gestation
- Admission to maternity ward for labor
- Age >14
Key exclusion criteria (1 listed)
- Pain >=8 on Wong-Baker FACES pain scale
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 |
|---|---|---|
| Video counselingVideo counseling | Other | Video counseling |
| Conversational counselingConversational counseling | Other | Conversational counseling |
Primary outcome
Total Counseling Time
Time frame: Immediately following the intervention, an average of less than 30 minutes
Duration of counseling in minutes (from initiation of counseling to conclusion of all questions answered.) The clock was not stopped for breaks, which were allowed as needed.
2 secondary outcomes
Knowledge Scores
Time frame: One hour
Number of Participants Initiating Postpartum LARC Uptake
Time frame: Assessed at the time of hospital discharge, on average less than 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29752923Hersh AR, Munoz LF, Rincon M, Alvarez C, Tolosa JE, Moreno DJ, Rubio M, Vargas JC, Edna F, Taborda N, Baldwin MK. Video compared to conversational contraceptive counseling during labor and maternity hospitalization in Colombia: A randomized trial. Contraception. 2018 Sep;98(3):210-214. doi: 10.1016/j.contraception.2018.05.004. Epub 2018 May 9.
- Individual participant dataSharing planned: No. Individual sites hold the paper data under monitoring plan through their site Institutional Review Board (IRB - University de Antioquia). They entered de-identified data electronically into REDCap for our use for analysis. We have shared aggregate analysis with the individual sites.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video counseling and Conversational counseling in people with Contraceptive Usage and Contraception Behavior, run by Oregon Health and Science University at 2 sites in Colombia.
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 3 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Counseling Time (time frame: Immediately following the intervention, an average of less than 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400449, which also lists 1 linked publication.
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 13 Nov 2019.