Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization

Contraceptive Usage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400449
• Other study ID #: 11331b
• Status: Completed
• Phase: N/A
• Start date: April 28, 2015
• Est. completion date: August 7, 2016

Study information

• Verified date: October 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized trial comparing LARC uptake and satisfaction after either video or conversational-based contraceptive counseling for pregnant women in labor.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 7, 2016
• Est. primary completion date: August 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception Behavior
• Contraceptive Usage

Intervention

Other:
• Video counseling
Video counseling
• Conversational counseling
Conversational counseling

Locations

Country	Name	City	State
Colombia	Maternidad Rafael Calvo	Cartagena
Colombia	Metrosalud Manrique	Medellín

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Immediately following the intervention, an average of less than 30 minutes
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.	One hour
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.	Assessed at the time of hospital discharge, on average less than 2 days