A Randomized Controlled Trial of Immediate Postpartum Etonogestrel Implant Versus Six-week Postpartum Etonogestrel Implant: A Pilot Study
| Registry | NCT01767285 |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: none, prevention |
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| Enrollment | 60 (Actual) |
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| Sponsor | Duke University (Other) |
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| Conditions | Continuation Rate of Contraceptive Implant |
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| Interventions | Etonogestrel implant (Drug) |
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| Dates | start 2013-01-01, primary completion 2015-04-01, completion 2015-04-01, first posted 2013-01-14, last updated 2017-02-28 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Continuation Rate of Contraceptive Implant All trials of Etonogestrel implant
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Immediate Postpartum Etonogestrel Implant | Experimental | Drug: Etonogestrel implant | Etonogestrel implant placed in the hospital after delivery, before discharge home. |
| Delayed postpartum etonogestrel implant | Active comparator | Drug: Etonogestrel implant | These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. |
- Etonogestrel implant (Drug), also known as Implanon, Nexplanon: 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.
+Outcome measures
Primary outcomes
- Continuation Rate [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 outcomes
- Rate of Intercourse [6 weeks]: To identify differences in the rates of intercourse prior to the 6-week postpartum visit.
- Continuation Rate [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 outcomes
- Continuation of Breastfeeding [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.
- Pregnancy Rate [12 months]: To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.
- Patient Satisfaction [12 months]: To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.
+Eligibility
Sex: Female, ages: 12 Years to 40 Years, accepts healthy volunteers
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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+Posted results
Participant flow
| Milestone | Immediate Postpartum Etonogestrel Implant | Delayed Postpartum Etonogestrel Implant |
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| Started | 29 | 30 |
| Completed | 22 | 24 |
| Not completed | 7 | 6 |
Outcome results
- Continuation Rate (Primary), Number, participants: Immediate Postpartum Etonogestrel Implant 20; Delayed Postpartum Etonogestrel Implant 18
- Rate of Intercourse (Secondary), Number, participants: Immediate Postpartum Etonogestrel Implant 8; Delayed Postpartum Etonogestrel Implant 14
- Continuation Rate (Secondary), Number, participants: Immediate Postpartum Etonogestrel Implant 27; Delayed Postpartum Etonogestrel Implant 21
- Continuation of Breastfeeding (Other pre specified), Number, participants: Immediate Postpartum Etonogestrel Implant 6; Delayed Postpartum Etonogestrel Implant 5
- Pregnancy Rate (Other pre specified), Number, participants: Immediate Postpartum Etonogestrel Implant 0; Delayed Postpartum Etonogestrel Implant 1
- Patient Satisfaction (Other pre specified), Number, participants: Immediate Postpartum Etonogestrel Implant 15; Delayed Postpartum Etonogestrel Implant 13
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Immediate Postpartum Etonogestrel Implant | 0 | 0/29 (0.0%) | 0/29 (0.0%) |
| Delayed Postpartum Etonogestrel Implant | 0 | 0/30 (0.0%) | 0/30 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
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| Duke University Medical Center | Durham, North Carolina | United States | |
+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. doi: 10.1363/psrh.38.090.06. PMID 16772190
- 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 21343774
- 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 20705154
- 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 20399949
- 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 10221230
- 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 15854630
- 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 19913145
- Results publication: 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 36302159
+Investigators
- Jessica Morse, MD, Principal investigator, Duke Hospital Department of Obstetrics and Gynecology