NCT01767285

Brief Summary

The investigators are examining if there is a difference in continuation rates of the etonogestrel contraceptive implant between women who have the device placed immediately after delivery, before leaving the hospital, and women who have the device placed at the routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete a brief survey. The investigators hypothesize that continuation rates of Implanon will be higher in the immediate postpartum placement arm than in the delayed placement arm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 19, 2016

Completed
Last Updated

February 28, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

January 7, 2013

Results QC Date

March 30, 2016

Last Update Submit

January 13, 2017

Conditions

Continuation Rate of Contraceptive Implant

Keywords

Etonogestrel ImplantImplanonNexplanonLong Acting Reversible Contraception

Outcome Measures

Primary Outcomes (1)

  • Continuation Rate

    To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.

    1 year

Secondary Outcomes (2)

  • Rate of Intercourse

    6 weeks

  • Continuation Rate

    6 months

Other Outcomes (3)

  • Continuation of Breastfeeding

    6 months

  • Pregnancy Rate

    12 months

  • Patient Satisfaction

    12 months

Study Arms (2)

Immediate Postpartum Etonogestrel Implant

EXPERIMENTAL

Etonogestrel implant placed in the hospital after delivery, before discharge home.

Drug: Etonogestrel implant

Delayed postpartum etonogestrel implant

ACTIVE COMPARATOR

These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.

Drug: Etonogestrel implant

Interventions

Etonogestrel implantDRUG

This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.

Also known as: Implanon, Nexplanon
Delayed postpartum etonogestrel implantImmediate Postpartum Etonogestrel Implant

Eligibility Criteria

Age12 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • )Age 12-40 years 2)Must deliver at Duke Hospital 3)Must have a working telephone number 4)No contraindications to receiving this method of contraception, which include: known or suspected pregnancy, active liver disease or hepatic tumor, current or past history of thrombosis or thromboembolic disorder, undiagnosed abnormal genital bleeding, known or suspected breast cancer or history of breast cancer, hypersensitivity to any of the components of the device.

You may not qualify if:

  • \. Non-nucleoside reverse transcriptase inhibitors 2. ritonavir-boosted protease inhibitors 3. Certain anticonvulsants - phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine 4. Rifampin 5. St. John's Wort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

Related Publications (8)

  • Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006 Jun;38(2):90-6. doi: 10.1363/psrh.38.090.06.

    PMID: 16772190BACKGROUND

  • Espey E, Ogburn T. Long-acting reversible contraceptives: intrauterine devices and the contraceptive implant. Obstet Gynecol. 2011 Mar;117(3):705-719. doi: 10.1097/AOG.0b013e31820ce2f0.

    PMID: 21343774BACKGROUND

  • Guazzelli CA, de Queiroz FT, Barbieri M, Torloni MR, de Araujo FF. Etonogestrel implant in postpartum adolescents: bleeding pattern, efficacy and discontinuation rate. Contraception. 2010 Sep;82(3):256-9. doi: 10.1016/j.contraception.2010.02.010. Epub 2010 Mar 29.

    PMID: 20705154BACKGROUND

  • Lewis LN, Doherty DA, Hickey M, Skinner SR. Implanon as a contraceptive choice for teenage mothers: a comparison of contraceptive choices, acceptability and repeat pregnancy. Contraception. 2010 May;81(5):421-6. doi: 10.1016/j.contraception.2009.12.006. Epub 2010 Jan 15.

    PMID: 20399949BACKGROUND

  • Croxatto HB, Urbancsek J, Massai R, Coelingh Bennink H, van Beek A. A multicentre efficacy and safety study of the single contraceptive implant Implanon. Implanon Study Group. Hum Reprod. 1999 Apr;14(4):976-81. doi: 10.1093/humrep/14.4.976.

    PMID: 10221230BACKGROUND

  • Funk S, Miller MM, Mishell DR Jr, Archer DF, Poindexter A, Schmidt J, Zampaglione E; Implanon US Study Group. Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005 May;71(5):319-26. doi: 10.1016/j.contraception.2004.11.007.

    PMID: 15854630BACKGROUND

  • Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009 Dec;80(6):519-26. doi: 10.1016/j.contraception.2009.05.124. Epub 2009 Jul 10.

    PMID: 19913145BACKGROUND

  • Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.

    PMID: 36302159DERIVED

MeSH Terms

Interventions

etonogestrel

Results Point of Contact

Title
Dr. Beverly Gray
Organization
Duke University
beverly.gray@dm.duke.edu
919-684-8111

Study Officials

  • Jessica Morse, MD

    Duke Hospital Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 14, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 28, 2017

Results First Posted

December 19, 2016

Record last verified: 2017-01

Locations

US(1)