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临床试验/NCT04257552
NCT04257552已完成不适用

Care After Pregnancy Study (CAPS): Randomized Controlled Trial of Patient Engagement After Pregnancy

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2020年2月3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
128
试验地点
2
主要终点
Number of Participants Using a Non-barrier Method of Contraception

研究概览

简要总结

The overarching hypothesis of our research agenda is that an intervention that engages economically disadvantaged women in personalized postpartum care will promote equality in maternal child health. As a first step to test our hypothesis the investigators propose the following aims:

Specific Aim 1: Measure the impact of Healthy Beyond Pregnancy on key components of postpartum care, including use of effective contraception at three and six months postpartum and breastfeeding duration at three and six months.

Specific Aim 2: Determine if Healthy Beyond Pregnancy improves adherence to health screening and linkage to follow-up care for women with cardio-metabolic complications of pregnancy.

详细描述

There are profound economic inequalities in a wide range of important maternal and child health outcomes ranging from neonatal death to maternal morbidity and mortality. The overarching scientific premise for our proposal is that these inequalities stem in part from poor engagement in postpartum care by economically disadvantaged women. The investigators hypothesize that an innovative intervention grounded in empirically derived tenets of behavioral economics that includes the critical components of the American College of Obstetricians and Gynecologists (ACOG) new vision for postpartum care will narrow gaps in important maternal child health outcomes.

Women of lower socioeconomic status are at significantly increased risk of unintended pregnancies, short inter-pregnancy interval and short duration of breastfeeding. The consequences of untimed pregnancies and short duration of breastfeeding for the health of mothers, infants and children are well documented. In addition to significant health implications, these inequalities have important economic ramifications. The cost of births from unintended pregnancies in 2006 was estimated at $11 billion in maternity and infant care. This does not include cost of abortion care, lost productivity, and government assistance.

Providers have effective postpartum strategies to reduce the risk of poorly timed pregnancies and low breastfeeding rates.

Short interval or poorly timed pregnancies: Women have a range of effective contraceptive options, however, not initiating contraception postpartum remains common. The provision of long-acting reversible contraception (LARC) including intrauterine devices (IUDs) and hormonal implants has been shown to decrease short interval pregnancies and the associated risk of preterm birth. Importantly, given the array of contraceptive options available to women, it is important to make LARC accessible while empowering women to choose a method that is effective and acceptable to them. This highlights the need for solutions to engage women in patient centered comprehensive contraceptive decision-making in the postpartum period.

Short Breastfeeding Duration: A number of strategies have been shown to increase breastfeeding success. Most relevant to our proposal is that efforts to educate women about the benefits of breastfeeding, weekly text reminders in the immediate postpartum period, and access to a lactation consultant have all improved both duration and exclusivity of breastfeeding. Importantly, three recent trials demonstrated significant increases in exclusive breastfeeding from eight weeks to six months postpartum among women who received weekly-automated text message breastfeeding support. These interventions may be particularly relevant to our target population, as low-income, non-Hispanic Black women between 18-29 years send and receive text messages more frequently than any other demographic.

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
Single (Investigator)

盲法说明

Investigators are unaware of study arm.

入排标准

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

入选标准

  • Insured by a PA Medicaid insurance
  • Pregnancy care in the Magee Womens Hospital Outpatient Clinic

排除标准

  • Delivery less than 24 weeks
  • Fetal or neonatal demise
  • Women who had a postpartum tubal ligation
  • Women less than 18 year of age

结局指标

主要结局

Number of Participants Using a Non-barrier Method of Contraception

时间窗: 6 months after delivery

Effective contraception (non-barrier method)

Adherence of Postpartum Visit

时间窗: 12 weeks after deliery

Attendance at postpartum visit (yes/no)

次要结局

  • The Number of Participants Who Given Their Infant Breast Milk(6 months after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Himes

Associate Professor of Medicine

University of Pittsburgh

研究点 (2)

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