Adolescent PregnancyPPCINCT01814930
Adolescent Postpartum Contraceptive Counseling Intervention
A study testing Brief standardized contraceptive counseling intervention in people with Adolescent Pregnancy, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Pregnancy
- What is being tested?
- Brief standardized contraceptive counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 14-19 years old
- primiparous
- immediately postpartum
- delivery of a full term live singleton infant (>37 weeks) at HUP
Who cannot join
- not planning to reside in/near Philadelphia for the next year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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
- Conditions
- Adolescent Pregnancy
- Being tested
- Brief standardized contraceptive counseling intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief standardized contraceptive counseling interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Routine postpartum contraceptive counseling |
| Individual counseling | Experimental | Brief standardized contraceptive counseling intervention Receives: Behavioral: Brief standardized contraceptive counseling intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is repeat pregnancy rate
Repeat pregnancy rate of intervention and control groups will be assessed
Measured: 1 year
Secondary outcomes (1)
Contraceptive choice, use and continuation rates postpartum as well as contraceptive satisfaction rates
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent PregnancyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney Schreiber, University of Pennsylvania
- Investigators
- Courtney A Schreiber, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814930
- Sponsor's protocol ID
- 814909
- Acronym
- PPCI
- Status last verified
- Jun 2014
- First submitted
- 18 Mar 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30470924
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Brief Standardized Postpartum Counseling Intervention's Effect on Repeat Pregnancy Rates Contraceptive Choice/Use/Continuation/Satisfaction in Adolescents
- ClinicalTrials.gov ID
- NCT01814930
- Acronym / sponsor ID
- PPCI / 814909
- Conditions
- Adolescent Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –Routine postpartum contraceptive counseling |
| Individual counseling | Experimental | Behavioral: Brief standardized contraceptive counseling interventionBrief standardized contraceptive counseling intervention |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 14-19 years old
- primiparous
- immediately postpartum
- delivery of a full term live singleton infant (>37 weeks) at HUP
Key exclusion criteria (1 listed)
- not planning to reside in/near Philadelphia for the next year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief standardized contraceptive counseling interventionThe 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. | Behavioural | Individual counseling |
Primary outcome
The primary outcome is repeat pregnancy rate
Time frame: 1 year
Repeat pregnancy rate of intervention and control groups will be assessed
1 secondary outcome
Contraceptive choice, use and continuation rates postpartum as well as contraceptive satisfaction rates
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
- Derived from this study: PubMed 30470924Frarey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney A Schreiber, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief standardized contraceptive counseling intervention in people with Adolescent Pregnancy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is repeat pregnancy rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01814930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014.