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. Author manuscript; available in PMC: 2013 Dec 7.
Published in final edited form as: Cochrane Database Syst Rev. 2013 Jul 2;7:CD008815. doi: 10.1002/14651858.CD008815.pub3

Characteristics of studies awaiting classification

Madden 2013
Methods Observational, cohort study; non-probability sample.
Purpose: learn whether women who use progestin-only methods will experience weight change compared to women using the non- hormonal copper IUD.
Primary hypothesis: users of DMPA will gain excess weight and increase their BMI above the copper-IUD users. Secondarily, compare users’ data in LNG-IUD and ENG implant groups to copper-IUD group.
Participants 427 women
Inclusion criteria: enrolled in CHOICE between the age 18 and 45 years and consented to future studies; chose levonorgestrel-releasing IUD, copper IUD, implant, or DMPA as CHOICE baseline method; baseline height and weight data collected from on-campus enrollment site; able to return to on-campus enrollment site for study activities.
Exclusion criteria: recent history of DMPA use before starting baseline CHOICE method; used current method < 11 months or > 12 months and 3 weeks.
Interventions DMPA, LNG-IUD, copper-T IUD, or implant.
Outcomes Weight change by 12 months
Notes After the updated review was submitted, the investigator communicated that an article was accepted for publication. Those results will be add to the next update. Note: Reportedly, the adjusted model indicated no significant difference between the study arms in weight gain.