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Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization

Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization: The COMSE Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03400449
Enrollment
240
Registered
2018-01-17
Start date
2015-04-28
Completion date
2016-08-07
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Usage, Contraception Behavior

Brief summary

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.

Interventions

Video counseling

OTHERConversational counseling

Conversational counseling

Sponsors

Universidad de Antioquia
CollaboratorOTHER
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Two groups randomized to counseling type.

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Live pregnancy \>20 weeks gestation * Admission to maternity ward for labor * Age \>14

Exclusion criteria

* Pain \>=8 on Wong-Baker FACES pain scale

Design outcomes

Primary

MeasureTime frameDescription
Total Counseling TimeImmediately following the intervention, an average of less than 30 minutesDuration 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.

Secondary

MeasureTime frameDescription
Knowledge ScoresOne hourMean 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.
Number of Participants Initiating Postpartum LARC UptakeAssessed at the time of hospital discharge, on average less than 2 daysNumber of participants initiating long-acting reversible contraception (LARC - intrauterine device (IUD) or implant) prior to hospital discharge.

Countries

Colombia

Participant flow

Participants by arm

ArmCount
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
120
Conversational Counseling
The conversation group participated in a structured, face-to-face conversation with a trained counselor. Conversational counseling: Conversational counseling
119
Total239

Baseline characteristics

CharacteristicConversational CounselingTotalVideo Counseling
Age, Categorical
<=18 years
23 Participants43 Participants20 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
96 Participants196 Participants100 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Colombia
119 participants239 participants120 participants
Sex: Female, Male
Female
119 Participants239 Participants120 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1200 / 119
other
Total, other adverse events
0 / 1200 / 119
serious
Total, serious adverse events
0 / 1200 / 119

Outcome results

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.

Time frame: Immediately following the intervention, an average of less than 30 minutes

ArmMeasureValue (MEAN)Dispersion
Video CounselingTotal Counseling Time16.8 minutesStandard Deviation 4.6
Conversational CounselingTotal Counseling Time16.3 minutesStandard Deviation 4.6
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.

Time frame: One hour

ArmMeasureGroupValue (MEAN)Dispersion
Video CounselingKnowledge ScoresPre-counseling3.1 score on a scaleStandard Deviation 1.5
Video CounselingKnowledge ScoresPost-counseling5.3 score on a scaleStandard Deviation 1
Conversational CounselingKnowledge ScoresPre-counseling3.1 score on a scaleStandard Deviation 1.5
Conversational CounselingKnowledge ScoresPost-counseling5.1 score on a scaleStandard Deviation 1.2
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.

Time frame: Assessed at the time of hospital discharge, on average less than 2 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Video CounselingNumber of Participants Initiating Postpartum LARC Uptake46 Participants
Conversational CounselingNumber of Participants Initiating Postpartum LARC Uptake44 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026