NCT03400449

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 19, 2019

Completed
Last Updated

November 13, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

December 20, 2017

Results QC Date

March 22, 2019

Last Update Submit

October 29, 2019

Conditions

Outcome Measures

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.

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

Secondary Outcomes (2)

  • Knowledge Scores

    One hour

  • Number of Participants Initiating Postpartum LARC Uptake

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

Study Arms (2)

Video counseling

ACTIVE COMPARATOR

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

Conversational counseling

ACTIVE COMPARATOR

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

Other: Conversational counseling

Interventions

Video counseling

Video counseling

Conversational counseling

Conversational counseling

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maternidad Rafael Calvo

Cartagena, Colombia

Location

Metrosalud Manrique

MedellĂ­n, Colombia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Results Point of Contact

Title
Ob/Gyn Regulatory Specialist
Organization
Oregon Health & Science University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups randomized to counseling type.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 20, 2017

First Posted

January 17, 2018

Study Start

April 28, 2015

Primary Completion

August 7, 2016

Study Completion

August 7, 2016

Last Updated

November 13, 2019

Results First Posted

June 19, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

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.

Locations