The Impact of Contraception on Postpartum Weight Loss (PPWL)

University of Pennsylvania

Status: Completed

Conditions: Weight

Treatments: Drug: DMPA immediately postpartum; Drug: Implanon immediately postpartum

Study type: Interventional

Funder types: Other

Identifiers

NCT02144259

813000

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

DMPA group

Active Comparator group

Description:

Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.

Treatment:

Drug: DMPA immediately postpartum

Implanon group

Active Comparator group

Description:

Subjects randomized to receive Implanon immediately post-partum.

Treatment:

Drug: Implanon immediately postpartum

Control group

No Intervention group

Description:

Subjects selecting their own method of contraception or no contraception.