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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Postpartum Etonogestrel Implant | Experimental | Etonogestrel implant placed in the hospital after delivery, before discharge home. |
|
| Delayed postpartum etonogestrel implant | Active Comparator | These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etonogestrel implant | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Intercourse | To identify differences in the rates of intercourse prior to the 6-week postpartum visit. | 6 weeks |
| Continuation Rate | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuation of Breastfeeding | To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement. | 6 months |
| Pregnancy Rate |
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. 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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| Name | Affiliation | Role |
|---|---|---|
| Jessica Morse, MD | Duke Hospital Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16772190 | Background | 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. | |
| 21343774 | Background | 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. |
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60 participants signed consent. 1 participant was a screen failure. 59 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Postpartum Etonogestrel Implant | Etonogestrel implant placed in the hospital after delivery, before discharge home. 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. |
| FG001 | Delayed Postpartum Etonogestrel Implant | These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Postpartum Etonogestrel Implant | Etonogestrel implant placed in the hospital after delivery, before discharge home. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed the 1 year phone visit were included in analysis. | Posted | Number | participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Postpartum Etonogestrel Implant | Etonogestrel implant placed in the hospital after delivery, before discharge home. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Beverly Gray | Duke University | 919-684-8111 | beverly.gray@dm.duke.edu |
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| ID | Term |
|---|---|
| C044815 | etonogestrel |
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|
| 6 months |
To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.
| 12 months |
| Patient Satisfaction | To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement. | 12 months |
| 20705154 | Background | 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. |
| 20399949 | Background | 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. |
| 10221230 | Background | 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. |
| 15854630 | Background | 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. |
| 19913145 | Background | 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. |
| 36302159 | Derived | 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. |
| BG001 |
| Delayed Postpartum Etonogestrel Implant |
These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. 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. |
|
|
| Secondary | Rate of Intercourse | To identify differences in the rates of intercourse prior to the 6-week postpartum visit. | Participants who completed the 6 week assessment. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | Continuation Rate | 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. | Participants who completed the 6 month assessment. | Posted | Number | participants | 6 months |
|
|
|
| Other Pre-specified | Continuation of Breastfeeding | To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement. | Participants who completed the 6 month assessment. | Posted | Number | participants | 6 months |
|
|
|
| Other Pre-specified | Pregnancy Rate | To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement. | all participants who completed the 12 month follow up visit | Posted | Number | participants | 12 months |
|
|
|
| Other Pre-specified | Patient Satisfaction | To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement. | Participants who completed the 12 month patient satisfaction assessment. | Posted | Number | participants | 12 months |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Delayed Postpartum Etonogestrel Implant | These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. 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. | 0 | 30 | 0 | 30 |
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