Continuation Rate of Contraceptive Implant
Conditions
Keywords
Etonogestrel Implant, Implanon, Nexplanon, Long Acting Reversible Contraception
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.
Interventions
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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 40 Years
Healthy volunteers
Yes
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. \-
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
60 participants signed consent. 1 participant was a screen failure. 59 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 30 |
| Total | 59 |
Baseline characteristics
| Characteristic | Immediate Postpartum Etonogestrel Implant | Delayed Postpartum Etonogestrel Implant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 30 Participants | 59 Participants |
| Gender Female | 29 Participants | 30 Participants | 59 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 29 participants | 29 participants | 58 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
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.
Time frame: 1 year
Population: Participants who completed the 1 year phone visit were included in analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Postpartum Etonogestrel Implant | Continuation Rate | 20 participants |
| Delayed Postpartum Etonogestrel Implant | Continuation Rate | 18 participants |
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.
Time frame: 6 months
Population: Participants who completed the 6 month assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Postpartum Etonogestrel Implant | Continuation Rate | 27 participants |
| Delayed Postpartum Etonogestrel Implant | Continuation Rate | 21 participants |
Secondary
Rate of Intercourse
To identify differences in the rates of intercourse prior to the 6-week postpartum visit.
Time frame: 6 weeks
Population: Participants who completed the 6 week assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Postpartum Etonogestrel Implant | Rate of Intercourse | 8 participants |
| Delayed Postpartum Etonogestrel Implant | Rate of Intercourse | 14 participants |
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.
Time frame: 6 months
Population: Participants who completed the 6 month assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Postpartum Etonogestrel Implant | Continuation of Breastfeeding | 6 participants |
| Delayed Postpartum Etonogestrel Implant | Continuation of Breastfeeding | 5 participants |
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.
Time frame: 12 months
Population: Participants who completed the 12 month patient satisfaction assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Postpartum Etonogestrel Implant | Patient Satisfaction | 15 participants |
| Delayed Postpartum Etonogestrel Implant | Patient Satisfaction | 13 participants |
Other Pre-specified
Pregnancy Rate
To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.
Time frame: 12 months
Population: all participants who completed the 12 month follow up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Postpartum Etonogestrel Implant | Pregnancy Rate | 0 participants |
| Delayed Postpartum Etonogestrel Implant | Pregnancy Rate | 1 participants |