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The Impact of Contraception on Postpartum Weight Loss (PPWL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02144259
Recruitment Status : Completed
First Posted : May 21, 2014
Results First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Weight Drug: DMPA immediately postpartum Drug: Implanon immediately postpartum Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Impact of Contraception on Postpartum Weight Loss: a Prospective Study
Study Start Date : April 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: DMPA group
Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.
 Drug: DMPA immediately postpartum
DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.
Other Name: DepoProvera, depot medroxyprogesterone acetate (DMPA)
Active Comparator: Implanon group
Subjects randomized to receive Implanon immediately post-partum.
 Drug: Implanon immediately postpartum
Implanon ® is a subdermal implant that contains 68mg of etonogestrel.
Other Name: etonogestrel implant
No Intervention: Control group
Subjects selecting their own method of contraception or no contraception.


Outcome Measures
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Primary Outcome Measures :
  1. Weight [ Time Frame: 6 months from postpartum (baseline) ]
    Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups


Secondary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: 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 Outcome Measures:
  1. Contraceptive Satisfaction [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144259


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Courtney A Schreiber, MD University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02144259    
Other Study ID Numbers: 813000
First Posted: May 21, 2014    Key Record Dates
Results First Posted: February 17, 2017
Last Update Posted: February 17, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes
Medroxyprogesterone Acetate
Medroxyprogesterone
Etonogestrel
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
 Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents