N/A
N=100
The Impact of Contraception on Postpartum Weight Loss
Weight
Bottom Line
View on ClinicalTrials.gov: NCT02144259 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Weight — 3.2; 6.8; 7.0 percent weight lost — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DMPA immediately postpartum (Drug); Implanon immediately postpartum (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
3.2; 6.8; 7.0 | <0.05 sig |
| SECONDARY Pregnancy Rate |
1; 1; 4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02144259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.