Immediate vs. Delayed Postpartum Etonogestrel Implant

• ClinicalTrials.gov Identifier: NCT01767285
• Recruitment Status: Completed
• First Posted: January 14, 2013
• Results First Posted: December 19, 2016
• Last Update Posted: February 28, 2017
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Continuation Rate of Contraceptive Implant	Drug: Etonogestrel implant	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Controlled Trial of Immediate Postpartum Etonogestrel Implant Versus Six-week Postpartum Etonogestrel Implant: A Pilot Study
• Study Start Date: January 2013
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: April 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Immediate Postpartum Etonogestrel Implant; Etonogestrel implant placed in the hospital after delivery, before discharge home.	Drug: 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.; Other Names: Implanon; Nexplanon
Active Comparator: Delayed postpartum etonogestrel implant; These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.	Drug: 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.; Other Names: Implanon; Nexplanon

Outcome Measures

Primary Outcome Measures :

1. Continuation Rate [ Time Frame: 1 year ]
   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.

Secondary Outcome Measures :

1. Rate of Intercourse [ Time Frame: 6 weeks ]
   To identify differences in the rates of intercourse prior to the 6-week postpartum visit.
2. Continuation Rate [ Time Frame: 6 months ]
   To identify a difference in continuation rates of Implanon® at one year between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.

Other Outcome Measures:

1. Continuation of Breastfeeding [ Time Frame: 6 months ]
   To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.
2. Pregnancy Rate [ Time Frame: 12 months ]
   To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.
3. Patient Satisfaction [ Time Frame: 12 months ]
   To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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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Exclusion Criteria:

1. Not meeting inclusion criteria
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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Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27701

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Jessica Morse, MD; Duke Hospital Department of Obstetrics and Gynecology

More Information

Publications:

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.

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. Review.

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.

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.

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.

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.

Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sá 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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01767285
• Other Study ID Numbers: Pro00030001
• First Posted: January 14, 2013
• Results First Posted: December 19, 2016
• Last Update Posted: February 28, 2017
• Last Verified: January 2017

Keywords provided by Duke University:

Etonogestrel Implant; Implanon; Nexplanon; Long Acting Reversible Contraception

Additional relevant MeSH terms:

Etonogestrel; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Female