NCT01814930

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

1.8 years

First QC Date

March 18, 2013

Last Update Submit

June 3, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is repeat pregnancy rate

    Repeat pregnancy rate of intervention and control groups will be assessed

    1 year

Secondary Outcomes (1)

  • Contraceptive choice, use and continuation rates postpartum as well as contraceptive satisfaction rates

    1 year

Study Arms (2)

Routine Care

NO INTERVENTION

Routine postpartum contraceptive counseling

Individual counseling

EXPERIMENTAL

Brief standardized contraceptive counseling intervention

Behavioral: Brief standardized contraceptive counseling intervention

Interventions

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.

Individual counseling

Eligibility Criteria

Age14 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Frarey A, Gurney EP, Sober S, Whittaker PG, Schreiber CA. Postpartum contraceptive counseling for first-time adolescent mothers: a randomized controlled trial. Arch Gynecol Obstet. 2019 Feb;299(2):361-369. doi: 10.1007/s00404-018-4969-0. Epub 2018 Nov 23.

Study Officials

  • Courtney A Schreiber, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Fellowship in Family Planning

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 20, 2013

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 4, 2014

Record last verified: 2014-06

Locations