Immediate vs. Delayed Postpartum Etonogestrel Implant

NCT ID: NCT01767285

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Continuation Rate of Contraceptive Implant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Immediate Postpartum Etonogestrel Implant

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

Group Type: EXPERIMENTAL

Etonogestrel implant

Intervention Type: DRUG

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.

Delayed postpartum etonogestrel implant

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

Group Type: ACTIVE_COMPARATOR

Etonogestrel implant

Intervention Type: DRUG

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.

Interventions

Etonogestrel implant

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.

Intervention Type: DRUG

Other Intervention Names

Implanon; Nexplanon

Eligibility Criteria

Inclusion Criteria

1)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.

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2. Use of chronic medical therapy that has an adverse interaction with etonogestrel. Medications that will be cause for exclusion from the study include:

1. 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

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• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Morse, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Hospital Department of Obstetrics and Gynecology

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16772190 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21343774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20705154 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20399949 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10221230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15854630 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19913145 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36302159 (View on PubMed)

Other Identifiers

Pro00030001

Identifier Type: -

Identifier Source: org_study_id