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临床试验/NCT04005391
NCT04005391已完成不适用

Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women: a Cluster-randomized Trial

University of Colorado, Denver3 个研究点 分布在 2 个国家目标入组 208 人开始时间: 2018年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
208
试验地点
3
主要终点
Number of Participants With Implant Use at Three Months

研究概览

简要总结

Abstract

Background: Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth.

Methods: This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided.

Discussion: A barrier to postpartum contraception is access to medications and devices. The study removes some access barriers (distance, time, cost) by providing contraception in the home. The community nurses were trained to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town, which is about an hour away by vehicle. Therefore, the study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within three months of childbirth. The potential implications of this study include: nurses may be able to be trained to safely provide contraceptives, including place implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period.

详细描述

Background and Rationale: Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth as well as to avoid future pregnancy in mothers who have achieved their desired family size. Proper pregnancy spacing can prevent maternal and perinatal morbidity and mortality. Globally, there is significant unmet need for postpartum contraception.

Historically, in the community of interest, which is in the rural Southwest corner of Guatemala bordering Mexico, a large majority (88%) of a convenience sample of women in the community-based care program self-reported postpartum contraceptive use. However, 72% of these women were using injectable contraceptives, which are considered short-acting, and are less effective at preventing unintended and closely spaced pregnancies; the second most common method was sterilization (21%). For the remaining women who did not seek sterilization or injectable contraceptives, 0.5% of them reportedly used contraceptive pills, 0.5% condoms, 0.5% lactational amenorrhea, and 1.6% reportedly relied on natural family planning. Less than 4% of women were using long-acting reversible contraceptives (intrauterine devices or implants), which are more effective at preventing unintended and closely spaced pregnancies than injectables. The providers in the community had not been trained in implant and intrauterine device placement, so the closest place to have a device placed was the most proximate town to the communities, which is an hour away by vehicle. Additional barriers discovered through qualitative research in the study communities found that barriers to family planning use historically included knowledge, access to methods, fear of adverse events, and a woman garnering her partner's approval. Community women's ideas for future educational programming included teaching about how birth control methods work, how to talk to partners about birth spacing, and myth debunking, and they requested the location and time of teaching to occur at peripartum and pediatric visits.

Therefore, based on this preliminary data, the prospective research question is: if community-based nurses are trained to place contraceptive implants, and they offer women placement in the home at their postpartum visit (among other routinely available contraceptive methods), will the ability to provide this service increase the uptake of contraceptive implants in our communities of interest?

Specific Objectives or Hypotheses: The specific objective of the study is to observe in this population where use of postpartum contraception is historically common among women, does home delivery of the contraceptive implant increase utilization of the device above the baseline rate of 3.2%. The investigators hypothesize, based on published data from other settings, that if women receive proper counseling about all contraceptive methods, uptake of long-acting reversible contraceptives, which in this study includes only the contraceptive implant, is about 50%.

The secondary objectives are to observe if the home-based contraceptive delivery intervention featured in this study is associated with overall increased contraceptive uptake, continuation, and satisfaction in the intervention compared to the control clusters. The hypothesis is that with increased uptake of the implant there will be longer continuation rates and more satisfaction in the intervention clusters. The investigators also hypothesize that increased contraceptive uptake, continuation, and satisfaction may be associated with reduced short interval repeat pregnancy rates so the study also aims to survey participants on their pregnancy status at enrollment, and three- and twelve-months after enrollment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • postpartum state
  • enrolled in the Madres Sanas program
  • able and willing to consent
  • meeting age criteria
  • not already received a contraceptive method

排除标准

  • unable or unwilling to provide informed consent
  • does not meet age criteria
  • has already used a contraceptive method
  • is pregnant

结局指标

主要结局

Number of Participants With Implant Use at Three Months

时间窗: Three months

次要结局

  • Contraceptive Satisfaction at Twelve Months(12 Months)
  • Number of Participants With Any Contraceptive Use at Three Months(3 Months)
  • Number of Participants With Contraceptive Continuation at Twelve Months(12 Months)
  • Number of Participants With Repeat Pregnancy at Twelve Months(12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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