CClinicalTrials.gg
CompletedNCT03400449Updated Nov 13, 2019Results posted

Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization

An interventional study of Video counseling and Conversational counseling in Contraceptive Usage and Contraception Behavior, sponsored by Oregon Health and Science University. Completed at 2 sites in Colombia. Open to female participants aged 14 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
14 Years to 45 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Contraceptive Usage
  • Contraception Behavior
03

Who can participate

Ages eligible
14 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pain >=8 on Wong-Baker FACES pain scale
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • Active comparator
    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.

    Other: Video counseling

  • Active comparator
    Conversational counseling

    The conversation group participated in a structured, face-to-face conversation with a trained counselor.

    Other: Conversational counseling

Interventions

  • OtherVideo counseling

    Video counseling

  • OtherConversational counseling

    Conversational counseling

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

06

Results

Posted Jun 19, 2019

Participant flow

Participant flow — Overall Study
MilestoneVideo CounselingConversational Counseling
Started121119
Completed120119
Not completed10

Outcome measures

PrimaryTotal 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
Reported as:
Mean · minutes
Total Counseling Time
minutesVideo CounselingConversational Counseling
Total Counseling Time16.8 ± 4.616.3 ± 4.6
SecondaryKnowledge 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
Reported as:
Mean · score on a scale
Knowledge Scores
score on a scaleConversational CounselingVideo Counseling
Pre-counseling3.1 ± 1.53.1 ± 1.5
Post-counseling5.3 ± 1.05.1 ± 1.2
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Initiating Postpartum LARC Uptake
ParticipantsConversational CounselingVideo Counseling
Number of Participants Initiating Postpartum LARC Uptake4644

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Video Counseling0/120 (0%)0/120 (0%)0/120 (0%)
Conversational Counseling0/119 (0%)0/119 (0%)0/119 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Video CounselingConversational CounselingTotal
<=18 years202343
Between 18 and 65 years10096196
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Video CounselingConversational CounselingTotal
Female120119239
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Video CounselingConversational CounselingTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Video CounselingConversational CounselingTotal
Colombia120119239
07

Study locations

2 sites
  • Maternidad Rafael Calvo
    Cartagena, Colombia
  • Metrosalud Manrique
    Medellín, Colombia
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Registry details

Key details

Study ID
NCT03400449
Lead sponsor
Oregon Health and Science University
Collaborators
Universidad de Antioquia
Responsible party
Maureen Baldwin (Assistant Professor, Oregon Health and Science University) — Principal investigator
First posted
Jan 17, 2018
Start date
Apr 28, 2015
Primary completion
Aug 7, 2016
Completion
Aug 7, 2016
Results posted
Jun 19, 2019
Last update
Nov 13, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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