Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. During prenatal care, participants will be consented and screened for enrollment. After delivery, these women will be assessed and consented for enrollment into the study. Women who consent for enrollment will be randomized. Women will be followed up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each follow up, women will be assessed for continuation of and satisfaction with this method of contraception.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 week postpartum contraceptive implant | Active Comparator | randomized to receive contraceptive implant at normal 6 week postpartum visit |
|
| Immediate postpartum contraceptive implant | Experimental | randomized to receive contraceptive implant prior to leaving the hospital postpartum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contraceptive implant | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuation at 1 Year | The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum. | 12-14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction | To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being "not satisfied at all" to 10 being "extremely satisfied." | 12 months |
| Rapid Repeat Pregnancy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants will not be eligible for participation if they have any contraindications to contraceptive implant use, including
Characteristics that would preclude involvement after delivery:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27514 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 6 Week Postpartum Contraceptive Implant | randomized to receive contraceptive implant at normal 6 week postpartum visit Contraceptive implant |
| FG001 | Immediate Postpartum Contraceptive Implant | randomized to receive contraceptive implant prior to leaving the hospital postpartum Contraceptive implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 6 Week Postpartum Contraceptive Implant | randomized to receive contraceptive implant at normal 6 week postpartum visit Contraceptive implant |
| BG001 | Immediate Postpartum Contraceptive Implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 at 1 Year | The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum. | Posted | Number | participants | 12-14 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 6 Week Postpartum Contraceptive Implant | randomized to receive contraceptive implant at normal 6 week postpartum visit Contraceptive implant |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy G. Bryant, Assistant Professor | UNC_ChapelHill | 919-843-5633 | amy_bryant@med.unc.edu |
Not provided
| ID | Term |
|---|---|
| D003270 | Contraceptive Agents |
| C044815 | etonogestrel |
| ID | Term |
|---|---|
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.
| 12 months |
randomized to receive contraceptive implant prior to leaving the hospital postpartum
Contraceptive implant
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Satisfaction | To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being "not satisfied at all" to 10 being "extremely satisfied." | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Rapid Repeat Pregnancy | To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum. | Posted | Number | 95% Confidence Interval | participants | 12 months |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Immediate Postpartum Contraceptive Implant | randomized to receive contraceptive implant prior to leaving the hospital postpartum Contraceptive implant | 0 | 48 | 0 | 48 |
Not provided
Not provided
Not provided
| D045506 | Therapeutic Uses |