Contraceptive Counseling in the Postpartum Period

June 30, 2022 updated by: University Hospitals Cleveland Medical Center
This is a prospective randomized control trial in which we propose an intervention in the immediate post-partum period to educate women about contraceptive options, particularly long acting reversible contraception (LARC) methods with an aim of increasing the amount of women who choose a LARC method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible participants will be identified in the post-partum period and will be randomized to one of two groups. The control group will receive the standard of care contraceptive counseling which includes any prenatal counseling they received as well as information from the nurse practitioner that rounds on them in the post-partum period. The intervention group will also receive the standard of care contraceptive counseling but will also watch a 10 minute video created by the CHOICE project which counsels on different contraceptive options. Both groups will fill out a pre-intervention questionnaire as well as a post-intervention questionnaire 24hrs later. The primary outcome will be which type of contraception each woman chooses. The secondary outcomes will include determining if the women come to their post-partum visits as well as if they get the method of contraception they chose on the post-partum floor.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women giving birth at University Hospitals Case Medical Center
  • Patient of the Women's Health Center
  • Women delivering only one child
  • Women receiving contraceptive counseling from the nurse practitioner that cares for the postpartum unit

Exclusion Criteria:

  • Severe neonatal complication at time of delivery (neonatal death, neonatal admission to the neonatal intensive care unit (NICU) except in cases of chorioamnionitis)
  • Severe maternal complication at time of delivery (patient requiring intensive care unit care, patient requiring hysterectomy at time of delivery)
  • Preterm delivery <34 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients will receive current standard postpartum contraceptive counseling.
Experimental: Intervention
Patients will receive current standard postpartum contraceptive counseling and will be shown a 10 minute video from the CHOICE project which outlines the different contraceptive options
Behavioral: Information in the form of a video
see intervention description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choice of contraceptive method
Time Frame: 24 hours post-intervention
Will be obtained through use of a questionnaire.
24 hours post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return to clinic for postpartum visit
Time Frame: 12 weeks post-intervention
Will use ambulatory electronic medical record (EMR) to determine if patient returned to clinic for follow up visit.
12 weeks post-intervention
Obtained desired method of contraception
Time Frame: 12 weeks post-intervention
Will use ambulatory EMR to determine if patient received her desired method of contraception.
12 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 1, 2015

First Submitted That Met QC Criteria

March 1, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 11-14-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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