Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization

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.

Study Overview

• Status: Completed
• Conditions: Contraception Behavior; Contraceptive Usage
• Intervention / Treatment: Other: Video counseling; Other: Conversational counseling

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Cartagena, Colombia
    • Maternidad Rafael Calvo
  • Medellín, Colombia
    • Metrosalud Manrique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Video counseling
Active Comparator: Conversational counseling; The conversation group participated in a structured, face-to-face conversation with a trained counselor.	Other: Conversational counseling; Conversational counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Universidad de Antioquia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2015
• Primary Completion (Actual): August 7, 2016
• Study Completion (Actual): August 7, 2016

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 11331b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No