PPCI: Adolescent Postpartum Contraceptive Counseling Intervention

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01814930

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adolescent Pregnancy	Behavioral: Brief standardized contraceptive counseling intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The primary outcome is repeat pregnancy rate [1 year]
Repeat pregnancy rate of intervention and control groups will be assessed

Secondary Outcome Measures

Contraceptive choice, use and continuation rates postpartum as well as contraceptive satisfaction rates [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 19 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Courtney Schreiber, Director, Fellowship in Family Planning, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01814930

Other Study ID Numbers:

814909

First Posted:

Mar 20, 2013

Last Update Posted:

Jun 4, 2014

Last Verified:

Jun 1, 2014

Additional relevant MeSH terms:

Contraceptive Agents

Study Results

No Results Posted as of Jun 4, 2014