ContraceptionNAPANCT02037919

Nexplanon Application Post-Abortion (NAPA)

A study testing Immediate Nexplanon Insertion and Post-op Nexplanon Insertion in people with Contraception and Abortion, Therapeutic, run by Family Planning Associates Medical Group, LTD at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Women who receive Nexplanon immediately post abortion will be significantly more likely to be using the device 6 months after the procedure than those assigned to receive the device 2-4 weeks after the procedure. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Contraception, Abortion, Therapeutic
What is being tested?: Immediate Nexplanon Insertion and Post-op Nexplanon Insertion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 148 participants
Where: 2 sitesUnited States
Study dates: Jun 2014to May 2017
Phase: Interventional
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age and older,
an intrauterine pregnancy > 14 weeks and <23 6/7 weeks gestation and desire termination of pregnancy
desire a Nexplanon for contraception
able to give informed consent in English
no contraindications to Nexplanon (based on U.S. CDC Medical Eligibility Criteria for Contraception) or D\&E

Who cannot join

unable to give informed consent
have any of the following medical conditions: active venous thromboembolism, known or suspected sex-steroid sensitive malignancies, current hepatic disease with abnormal liver function tests, undiagnosed vaginal bleeding, hypersensitivity to any of the ingredients in Nexplanon.
non-surgical management of pregnancy
prior participation in this study
breast cancer or a history of breast cancer

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Family Planning Associates Medical Grooup, LTD
Chicago, Illinois, 60661
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Immediate vs. Delayed Insertion of Nexplanon After Termination of Pregnancy Over 14-weeks Gestation (NAPA)

Read the detailed description

Women will be contacted 6 months after their abortion to ask about contraception use and side effects.

Conditions: Contraception, Abortion, Therapeutic
Being tested: Immediate Nexplanon Insertion, Post-op Nexplanon Insertion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immediate Nexplanon InsertionOther
Patient will have a Nexplanon inserted within 15 minutes of her abortion
Post-op Nexplanon InsertionOther
Place Nexplanon at post operative visit rather than at surgery

Study groups in NCT02037919
Study group	Role	What they receive
Immediate Nexplanon Insertion	Experimental	An etonogestrel rod will be placed within 15 minutes following the abortion procedure. Receives: Other: Immediate Nexplanon Insertion
Post-op Nexplanon Insertion	Active comparator	Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure. Receives: Other: Post-op Nexplanon Insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

Intention-to-treat Analysis of Etonogestrel Implant Use
Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with all entire sample used in calculations.
Measured: 6 months
Per-protocol Analysis of Etonogestrel Implant Use
Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with only participants who completed the 6-month follow-up used in calculations.
Measured: 6 months

Secondary outcomes (1)

Repeat Pregnancy
Occurrence of a pregnancy within 6 months after second-trimester abortion.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014May 2017

First posted16 Jan 2014 (estimated)
Study startJun 2014
Primary completionMay 2017
Study completionMay 2017

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 ContraceptionStudies of the same condition, open and under way.
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
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02037919
Sponsor's protocol ID: IIS#50302: Women's Health MISP
Acronym: NAPA
Status last verified: Feb 2024
First submitted: 14 Jan 2014
Last updated: 12 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Contraception trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immediate vs. Delayed Insertion of Nexplanon After Termination of Pregnancy Over 14-weeks Gestation (NAPA)
ClinicalTrials.gov ID: NCT02037919
Acronym / sponsor ID: NAPA / IIS#50302: Women's Health MISP
Conditions: Contraception, Abortion, Therapeutic
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: Family Planning Associates Medical Group, LTDUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC, The Cleveland Clinic
Study start: Jun 2014
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 16 Jan 2014 (estimated)
Results: Posted 12 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Women will be contacted 6 months after their abortion to ask about contraception use and side effects.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate Nexplanon Insertion	Experimental	Other: Immediate Nexplanon InsertionAn etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Post-op Nexplanon Insertion	Active comparator	Other: Post-op Nexplanon InsertionParticipants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 years of age and older,
an intrauterine pregnancy > 14 weeks and <23 6/7 weeks gestation and desire termination of pregnancy
desire a Nexplanon for contraception
able to give informed consent in English
no contraindications to Nexplanon (based on U.S. CDC Medical Eligibility Criteria for Contraception) or D\&E

Key exclusion criteria (5 listed)

unable to give informed consent
have any of the following medical conditions: active venous thromboembolism, known or suspected sex-steroid sensitive malignancies, current hepatic disease with abnormal liver function tests, undiagnosed vaginal bleeding, hypersensitivity to any of the ingredients in Nexplanon.
non-surgical management of pregnancy
prior participation in this study
breast cancer or a history of breast cancer

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
Immediate Nexplanon InsertionPatient will have a Nexplanon inserted within 15 minutes of her abortion	Other	Immediate Nexplanon Insertion
Post-op Nexplanon InsertionPlace Nexplanon at post operative visit rather than at surgery	Other	Post-op Nexplanon Insertion

Primary outcome

Intention-to-treat Analysis of Etonogestrel Implant Use
Time frame: 6 months
Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with all entire sample used in calculations.
Per-protocol Analysis of Etonogestrel Implant Use
Time frame: 6 months
Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with only participants who completed the 6-month follow-up used in calculations.

1 secondary outcome

Repeat Pregnancy
Time frame: 6 months

Results and safety

Results posted to the registry on 12 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate Nexplanon Insertion	73	43
Post-op Nexplanon Insertion	75	30

Primary outcome: Intention-to-treat Analysis of Etonogestrel Implant Use

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Immediate Nexplanon Insertion n = 73	Post-op Nexplanon Insertion n = 75
Using implant at 6 months	40	19
Implant removed before 6 months	3	3

Primary outcome: Per-protocol Analysis of Etonogestrel Implant Use

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Immediate Nexplanon Insertion n = 43	Post-op Nexplanon Insertion n = 30
Using implant at 6 months	40	19
Implant removed before 6 months	3	3
Implant never placed	0	8

Population analysed: Calculated using only participants who completed the 6-month follow-up.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Nexplanon Insertion	0 of 73 (0%)	2 of 73 (2.7%)	0 of 73
Post-op Nexplanon Insertion	0 of 75 (0%)	1 of 75 (1.3%)	0 of 75

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
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RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
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Not yet recruiting
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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.

Miriam Cremer, MD, MPH principal investigator

University of Pittsburgh

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 12 Feb 2024). 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?

Intention-to-treat Analysis of Etonogestrel Implant Use (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02037919.

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 12 Feb 2024.