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临床试验/NCT02341027
NCT02341027已完成不适用

Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
205
试验地点
1
主要终点
Implant utilization as measured by the proportion of women using LNG contraceptive implants at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6-8 weeks after delivery (delayed insertion).

研究概览

简要总结

This study will evaluate if immediate postpartum placement of a levonorgestrel (LNG) contraceptive implant within 5 days of delivery improves implant utilization at 6 months postpartum compared to implant placement at 6-8 weeks postpartum among women in Uganda.

详细描述

Waiting until 6 weeks postpartum to initiate contraception puts women at risk for unintended pregnancy and short birth intervals. Short birth intervals of less than 18 months are associated with an increased risk of preterm delivery and low birth weight infants.

Subdermal implants are advantageous for the postpartum period because they are long-acting, reversible, and highly effective, and they do not contain estrogen or require intrauterine placement. In observational studies postpartum continuation rates have been shown to be greater than 95% after 6 months and 86-87% after 1 year in US populations. Implants are not routinely available during the immediate postpartum period in Uganda, and availability could improve the contraceptive method mix for postpartum women in that country. The results of this study may support increasing access to a form of immediate postpartum LARC (long acting reversible contraception) in a developing country.

This is a randomized, controlled trial of the association between immediate postpartum contraceptive implant placement and implant utilization at 6 months postpartum among women in Uganda. This study will compare the proportion of women using the Levonorgestrel contraceptive implant at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6 weeks after delivery (delayed insertion). The study population is women who have a delivery at Mulago hospital in Kampala, Uganda and choose a contraceptive implant for postpartum contraception.

The investigators plan to enroll 202 women who are planning to receive a postpartum Levonorgestrel contraceptive implant after delivery to find out whether the timing of postpartum administration of the implant (prior to hospital discharge or 6 weeks after delivery) affects implant utilization, satisfaction with the implant, vaginal bleeding or breastfeeding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 - 50 years old
  • Voluntarily requesting contraceptive implants for postpartum contraception
  • Vaginal delivery or cesarean delivery at Mulago Hospital
  • Willing and able to give informed consent
  • Agree to a possible home visit for follow up
  • Access to a cellphone for the duration of the study

排除标准

  • Current breast cancer or breast cancer within the past 5 years
  • Decompensated cirrhosis or a liver tumor
  • Unexplained vaginal bleeding prior to pregnancy
  • Current (or planned) use of Efavirenz medication

结局指标

主要结局

Implant utilization as measured by the proportion of women using LNG contraceptive implants at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6-8 weeks after delivery (delayed insertion).

时间窗: 6 months

次要结局

  • Time to lactogenesis measured by self-reported onset of lactogenesis.(72 hours)
  • Breastfeeding continuation rates as measured by self-report over the initial 6 months.(6 months)
  • Change in percentile in infant weight, length and head circumference from delivery to 6 weeks and from delivery to 6 months.(Birth to 6 months)
  • Pregnancy(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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