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Completed

NCT Number: NCT03400449

Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization

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

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Key information

Conditions

Contraceptive Usage Behavior Contraception Behavior Reproductive Behavior

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternidad Rafael Calvo, Cartagena, Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video Counseling

Other

Video counseling

Conversational counseling

Other

Conversational counseling

Primary outcomes

  1. Total Counseling Time

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

    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.

Secondary outcomes

  1. Knowledge Scores

    Time frame: One hour

    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.

  2. Number of Participants Initiating Postpartum LARC Uptake

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

    Number of participants initiating long-acting reversible contraception (LARC - intrauterine device (IUD) or implant) prior to hospital discharge.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Universidad de Antioquia

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 17, 2018
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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