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| Name | Class |
|---|---|
| Universidad de Antioquia | OTHER |
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A randomized trial comparing LARC uptake and satisfaction after either video or conversational-based contraceptive counseling for pregnant women in labor.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Conversational counseling | Active Comparator | The conversation group participated in a structured, face-to-face conversation with a trained counselor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video counseling | Other | Video counseling |
| |
| Conversational counseling |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately following the intervention, an average of less than 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternidad Rafael Calvo | Cartagena | Colombia | ||||
| Metrosalud Manrique |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29752923 | Derived | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Video Counseling | 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. Video counseling: Video counseling |
| FG001 | Conversational Counseling | The conversation group participated in a structured, face-to-face conversation with a trained counselor. Conversational counseling: Conversational counseling |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Video Counseling | 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. Video counseling: Video counseling |
| BG001 | Conversational Counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes | Immediately following the intervention, an average of less than 30 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Video Counseling | 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. Video counseling: Video counseling |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ob/Gyn Regulatory Specialist | Oregon Health & Science University | 5034940757 | mccrimmo@ohsu.edu |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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Two groups randomized to counseling type.
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| Other |
Conversational counseling |
|
| 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. |
| Assessed at the time of hospital discharge, on average less than 2 days |
| Medellín |
| Colombia |
The conversation group participated in a structured, face-to-face conversation with a trained counselor. Conversational counseling: Conversational counseling |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | One hour |
|
|
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| Secondary | 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. | Posted | Count of Participants | Participants | Assessed at the time of hospital discharge, on average less than 2 days |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
| EG001 | Conversational Counseling | The conversation group participated in a structured, face-to-face conversation with a trained counselor. Conversational counseling: Conversational counseling | 0 | 119 | 0 | 119 | 0 | 119 |
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