NCT02037919

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

February 12, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

January 14, 2014

Results QC Date

September 10, 2018

Last Update Submit

February 7, 2024

Conditions

ContraceptionAbortion, Therapeutic

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 months

Secondary Outcomes (1)

  • Repeat Pregnancy

    6 months

Other Outcomes (2)

  • Implant Inserted

    Within 4 weeks of abortion

  • Completed 6-month Phone Call

    6 months

Study Arms (2)

Immediate Nexplanon Insertion

EXPERIMENTAL

An etonogestrel rod will be placed within 15 minutes following the abortion procedure.

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.

Other: Post-op Nexplanon Insertion

Interventions

Immediate Nexplanon InsertionOTHER

Patient will have a Nexplanon inserted within 15 minutes of her abortion

Immediate Nexplanon Insertion
Post-op Nexplanon InsertionOTHER

Place Nexplanon at post operative visit rather than at surgery

Post-op Nexplanon Insertion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Family Planning Associates Medical Grooup, LTD

Chicago, Illinois, 60661, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Results Point of Contact

Title
Allison A. Cowett, MD MPH
Organization
Family Planning Associates Medical Group , Ltd.
aacowett@gmail.com
312-707-8988

Study Officials

  • Miriam Cremer, MD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Medical Director

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

February 12, 2024

Results First Posted

February 12, 2024

Record last verified: 2024-02

Locations

US(2)