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This is a prospective mixed methods study to assess weight changes in women randomized to receive Implanon ® or Depo Provera® (DMPA) immediately postpartum compared to women who choose non-hormonal contraception or no contraception immediately postpartum. After enrollment, subjects return for a visit at 3, 6 and 12 months postpartum to be asked a series of questions, take a pregnancy test, and be weighed. Total length of participation for each subject is 1 year or until pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMPA group | Active Comparator | Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. |
|
| Implanon group | Active Comparator | Subjects randomized to receive Implanon immediately post-partum. |
|
| Control group | No Intervention | Subjects selecting their own method of contraception or no contraception. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMPA immediately postpartum | Drug | DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups | 6 months from postpartum (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate | The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive Satisfaction | Satisfaction will be measured in response to the question, "How satisfied are you with your current birth control method?" This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from "Very Good" to "Very Poor". "Good" or "Very Good" responses will be analyzed as having been satisfied with the method. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney A Schreiber, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DMPA Group | Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate. |
| FG001 | Implanon Group | Subjects randomized to receive Implanon immediately post-partum. Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel. |
| FG002 | Control Group | Subjects selecting their own method of contraception or no contraception. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DMPA Group | Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate. |
| BG001 | Implanon Group |
| 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 | Weight | Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups | Posted | Mean | Standard Deviation | percent weight lost | 6 months from postpartum (baseline) |
|
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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 | DMPA Group | Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate. |
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First, we chose to exclude nursing women. Second, we had a small sample with power to detect one standard deviation difference in weight loss. Third, all data were collected prospectively,thus we did not have each participant's pre-pregnancy weight.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Courtney Schreiber | University of Pennsylvania | 215-615-5234 | courtney.schreiber@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017258 | Medroxyprogesterone Acetate |
| C044815 | etonogestrel |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
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| Implanon immediately postpartum | Drug | Implanon ® is a subdermal implant that contains 68mg of etonogestrel. |
|
|
| 1 year |
Subjects randomized to receive Implanon immediately post-partum.
Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.
| BG002 | Control Group | Subjects selecting their own method of contraception or no contraception. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Control Group |
Subjects selecting their own method of contraception or no contraception. |
|
|
|
| Secondary | Pregnancy Rate | The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant. | Posted | Number | number of pregnancies | 1 year |
|
|
|
| Other Pre-specified | Contraceptive Satisfaction | Satisfaction will be measured in response to the question, "How satisfied are you with your current birth control method?" This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from "Very Good" to "Very Poor". "Good" or "Very Good" responses will be analyzed as having been satisfied with the method. | Posted | Number | percentage of women satisfied w. method | 1 year |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Implanon Group | Subjects randomized to receive Implanon immediately post-partum. Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel. | 0 | 33 | 0 | 33 |
| EG002 | Control Group | Subjects selecting their own method of contraception or no contraception. | 0 | 34 | 0 | 34 |
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| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |