Adolescent Postpartum Contraceptive Counseling Intervention (PPCI)

June 3, 2014 updated by: Courtney Schreiber, University of Pennsylvania

Evaluation of a Brief Standardized Postpartum Counseling Intervention's Effect on Repeat Pregnancy Rates Contraceptive Choice/Use/Continuation/Satisfaction in Adolescents

Postpartum contraceptive counseling varies widely in its provision; no standardized practice has been well-established by the literature. We intend to evaluate how directed postpartum contraceptive counseling to adolescents aged 14-19 affects key outcomes over time. Subjects will be randomized to receive either the standardized contraceptive counseling intervention or routine postpartum care. We will then assess the difference in repeat pregnancy rates between the two groups

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

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

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 14-19 years old
  • primiparous
  • immediately postpartum
  • delivery of a full term live singleton infant (>37 weeks) at HUP

Exclusion Criteria:

  • not planning to reside in/near Philadelphia for the next year

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine Care
Routine postpartum contraceptive counseling
Experimental: Individual counseling
Brief standardized contraceptive counseling intervention
Behavioral: Brief standardized contraceptive counseling intervention
The intervention employed an in-person counseling strategy that included empowerment messaging and an instrument to clarify the participants' preferences for contraception in the context of their goals for future childbearing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome is repeat pregnancy rate
Time Frame: 1 year
Repeat pregnancy rate of intervention and control groups will be assessed
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Contraceptive choice, use and continuation rates postpartum as well as contraceptive satisfaction rates
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Courtney A Schreiber, MD, University of Pennsylvania

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

March 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 20, 2013

Study Record Updates

Last Update Posted (Estimate)

June 4, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 814909

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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