AdolescencePhase 4PPImplantNCT01666912
Postpartum Etonogestrel Implant for Adolescents
A Phase 4 study testing Contraceptive implant in people with Adolescence and Contraception, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. Read more about this study
- Who is it for?
- Ages 14 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescence, Contraception, Postpartum
- What is being tested?
- Contraceptive implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents ages 14-24 attending prenatal care
- Greater than 20 weeks estimated gestational age
- English or Spanish-speaking
- Desire to use the contraceptive implant for contraception postpartum
- Anticipated delivery of a healthy infant vaginally or by cesarean.
Who cannot join
- Participants will not be eligible for participation if they have any contraindications to contraceptive implant use, including
- current or past history of thrombosis or thromboembolic disorders
- hepatic tumors (benign or malignant)
- active liver disease
- undiagnosed abnormal genital bleeding
- known or suspected carcinoma of the breast (or a personal history of breast cancer)
Show all 17Show fewer
- hypersensitivity to any of the components of the contraceptive implant.
- Current use of any medications known to induce hepatic enzymes, including but not limited to: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, or topiramate
- Characteristics that would preclude involvement after delivery:
- Birth of a stillborn infant.
- Maternal ICU admission after delivery
- Maternal postpartum hemorrhage requiring blood transfusion
- Prolonged hospital stay (>7 days) postpartum
- Coagulopathy associated with the pregnancy
- Severe pregnancy-induced hypertension
- Fever >38 degrees C postpartum
- Adolescent women who are not competent to consent, secondary to stress from the labor process, for example severe pain or sleep deprivation, will not be offered enrolment into the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514
About this study
Official title: Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial
This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. During prenatal care, participants will be consented and screened for enrollment. After delivery, these women will be assessed and consented for enrollment into the study. Women who consent for enrollment will be randomized. Women will be followed up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each follow up, women will be assessed for continuation of and satisfaction with this method of contraception.
- Conditions
- Adolescence, Contraception, Postpartum
- Being tested
- Contraceptive implant
- Keywords
- adolescence, contraception, postpartum, rapid repeat pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive implantDrug
Also called Implanon, Nexplanon, etonogestrel contraceptive implant
| Study group | Role | What they receive |
|---|---|---|
| 6 week postpartum contraceptive implant | Active comparator | randomized to receive contraceptive implant at normal 6 week postpartum visit Receives: Drug: Contraceptive implant |
| Immediate postpartum contraceptive implant | Experimental | randomized to receive contraceptive implant prior to leaving the hospital postpartum Receives: Drug: Contraceptive implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation at 1 Year
The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.
Measured: 12-14 months
Secondary outcomes (2)
Satisfaction
To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being "not satisfied at all" to 10 being "extremely satisfied."
Measured: 12 months
Rapid Repeat Pregnancy
To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AdolescenceStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Bryant, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666912
- Sponsor's protocol ID
- PPI-12-0732
- Acronym
- PPImplant
- Status last verified
- Mar 2017
- First submitted
- 14 Aug 2012
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01666912
- Acronym / sponsor ID
- PPImplant / PPI-12-0732
- Conditions
- Adolescence, Contraception, Postpartum
- Keywords
- adolescence, contraception, postpartum, rapid repeat pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Posted 1 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. During prenatal care, participants will be consented and screened for enrollment. After delivery, these women will be assessed and consented for enrollment into the study. Women who consent for enrollment will be randomized. Women will be followed up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each follow up, women will be assessed for continuation of and satisfaction with this method of contraception.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 week postpartum contraceptive implant | Active comparator | Drug: Contraceptive implantrandomized to receive contraceptive implant at normal 6 week postpartum visit |
| Immediate postpartum contraceptive implant | Experimental | Drug: Contraceptive implantrandomized to receive contraceptive implant prior to leaving the hospital postpartum |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescents ages 14-24 attending prenatal care
- Greater than 20 weeks estimated gestational age
- English or Spanish-speaking
- Desire to use the contraceptive implant for contraception postpartum
- Anticipated delivery of a healthy infant vaginally or by cesarean.
Key exclusion criteria (17 listed)
- Participants will not be eligible for participation if they have any contraindications to contraceptive implant use, including
- current or past history of thrombosis or thromboembolic disorders
- hepatic tumors (benign or malignant)
- active liver disease
- undiagnosed abnormal genital bleeding
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 |
|---|---|---|
| Contraceptive implantAlso: Implanon, Nexplanon, etonogestrel contraceptive implant | Drug | 6 week postpartum contraceptive implant, Immediate postpartum contraceptive implant |
Primary outcome
Continuation at 1 Year
Time frame: 12-14 months
The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.
2 secondary outcomes
Satisfaction
Time frame: 12 months
Rapid Repeat Pregnancy
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contraceptive implant in people with Adolescence and Contraception, run by University of North Carolina, Chapel Hill 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 5 inclusion and 17 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 1 May 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Continuation at 1 Year (time frame: 12-14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2017.