The Impact of Contraception on Postpartum Weight Loss

NCT ID: NCT02144259

Last Updated: 2017-02-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-10-31

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.

Detailed Description

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Conditions

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Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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DMPA group

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

Group Type ACTIVE_COMPARATOR

DMPA immediately postpartum

Intervention Type DRUG

DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.

Implanon group

Subjects randomized to receive Implanon immediately post-partum.

Group Type ACTIVE_COMPARATOR

Implanon immediately postpartum

Intervention Type DRUG

Implanon ® is a subdermal implant that contains 68mg of etonogestrel.

Control group

Subjects selecting their own method of contraception or no contraception.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DMPA immediately postpartum

DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.

Intervention Type DRUG

Implanon immediately postpartum

Implanon ® is a subdermal implant that contains 68mg of etonogestrel.

Intervention Type DRUG

Other Intervention Names

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DepoProvera, depot medroxyprogesterone acetate (DMPA) etonogestrel implant

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Courtney A Schreiber, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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813000

Identifier Type: -

Identifier Source: org_study_id

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