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OpenTrials
Completed

NCT Number: NCT02144259

The Impact of Contraception on Postpartum Weight Loss

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.

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Key information

Conditions

Weight Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DMPA immediately postpartum

Drug

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

Other names: DepoProvera, depot medroxyprogesterone acetate (DMPA)

Implanon immediately postpartum

Drug

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

Other names: etonogestrel implant

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: PPWL

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 21, 2014
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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