Weight
Conditions
Brief summary
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.
Interventions
DRUGDMPA immediately postpartum
DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.
DRUGImplanon immediately postpartum
Implanon ® is a subdermal implant that contains 68mg of etonogestrel.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking * Aged 18-45 at enrollment (inclusive) * Immediately postpartum of a live singleton infant, 37 weeks gestation, at HUP * Desiring to delay another pregnancy for 6 months * Willing and able to follow the study protocol
Exclusion criteria
* Breastfeeding during study participation * Plans for relocation outside of Philadelphia in the next six months * Plans for use of weight loss medication or diet pills in the next six months * Women who wish to start Implanon ® or DMPA prior to discharge but who do not want to be randomized. 5. Issues or concerns in the judgment of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 6 months from postpartum (baseline) | Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate | 1 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Contraceptive Satisfaction | 1 year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Implanon Group Subjects randomized to receive Implanon immediately post-partum.
Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel. | 33 |
| Control Group Subjects selecting their own method of contraception or no contraception. | 34 |
| Total | 100 |
Baseline characteristics
| Characteristic | DMPA Group | Implanon Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 23.06 years STANDARD_DEVIATION 4.68 | 22.42 years STANDARD_DEVIATION 3.81 | 26.59 years STANDARD_DEVIATION 5.42 | 24.02 years STANDARD_DEVIATION 4.63 |
| Gender Female | 33 Participants | 33 Participants | 34 Participants | 100 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 33 participants | 33 participants | 34 participants | 100 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 | 0 / 34 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 | 0 / 34 |
Outcome results
Primary
Weight
Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups
Time frame: 6 months from postpartum (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DMPA Group | Weight | 3.2 percent weight lost | Standard Deviation 9.1 |
| Implanon Group | Weight | 6.8 percent weight lost | Standard Deviation 8.1 |
| Control Group | Weight | 7.0 percent weight lost | Standard Deviation 10.2 |
Comparison: Because the expected amount of postpartum weight loss in non-breastfeeding women is not documented in the literature, we chose a sample size that would enable us to detect a one standard deviation difference in weight loss between the 3 groups at the primary 6 month endpoint. We used generalized estimating equations (GEEs) to test differences among all 3 groups over all the study periods.p-value: <0.05GEE
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DMPA Group | Pregnancy Rate | 1 number of pregnancies |
| Implanon Group | Pregnancy Rate | 1 number of pregnancies |
| Control Group | Pregnancy Rate | 4 number of pregnancies |
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DMPA Group | Contraceptive Satisfaction | 74 percentage of women satisfied w. method |
| Implanon Group | Contraceptive Satisfaction | 89 percentage of women satisfied w. method |
| Control Group | Contraceptive Satisfaction | 75 percentage of women satisfied w. method |
p-value: <0.05Chi-squared