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临床试验/NCT02144259
NCT02144259已完成不适用

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

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Weight

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.
  • 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

研究组 & 干预措施

DMPA group

Active Comparator

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

干预措施: DMPA immediately postpartum (Drug)

Implanon group

Active Comparator

Subjects randomized to receive Implanon immediately post-partum.

干预措施: Implanon immediately postpartum (Drug)

结局指标

主要结局

Weight

时间窗: 6 months from postpartum (baseline)

Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups

次要结局

  • Pregnancy Rate(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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