The Impact of Contraception on Postpartum Weight Loss

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Contraception on Postpartum Weight Loss: a Prospective Study

Conditions
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Weight

Intervention / Treatment
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* Drug: DMPA immediately postpartum
* Drug: Implanon immediately postpartum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DMPA group<br>Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. | Drug: DMPA immediately postpartum<br>* DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.<br>* Other names: DepoProvera, depot medroxyprogesterone acetate (DMPA);|
| Active Comparator: Implanon group<br>Subjects randomized to receive Implanon immediately post-partum. | Drug: Implanon immediately postpartum<br>* Implanon ® is a subdermal implant that contains 68mg of etonogestrel.<br>* Other names: etonogestrel implant;|
| No Intervention: Control group<br>Subjects selecting their own method of contraception or no contraception. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |