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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01814930
Other study ID # 814909
Secondary ID
Status Completed
Phase N/A
First received March 18, 2013
Last updated June 3, 2014
Start date March 2012
Est. completion date December 2013

Study information

Verified date June 2014
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 19 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome is repeat pregnancy rate Repeat pregnancy rate of intervention and control groups will be assessed 1 year No
Secondary Contraceptive choice, use and continuation rates postpartum as well as contraceptive satisfaction rates 1 year No
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