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临床试验/NCT06915259
NCT06915259进行中(未招募)不适用

Doula Model of Care, A Randomized Controlled Trial

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2025年4月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
230
试验地点
1
主要终点
Edinburgh Postpartum Depression Scale (EPDS) score

研究概览

简要总结

The goal of this randomized controlled intervention trial is to determine if an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP), will improve both the experience and outcomes for Black birthing people.

The main question it aims to answer is whether an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP) will mitigate bias and mistrust thereby improving both the experience and outcomes for Black birthing people, assessed by the primary outcome of depression score.

Participants will be randomized to Doula care (receive 2 prenatal visits, continuous intrapartum support, and 2 postpartum visits with a certified doula) or standard of care (receive prenatal care, labor and delivery, and postpartum care as they normally would if not in the study) and followed through 6 weeks postpartum.

详细描述

Integrated bi-directional partnerships between birthing facilities, health care providers and community leaders and community birth support persons, such as doulas, is critical to improving health equity and maternal outcomes. This study is partnering with a birth worker/community support organization, with a mission to celebrate Black motherhood and influence favorable outcomes in Black Maternal Health by promoting a community-empowered model of care.

The United States has one of the largest racial and ethnic disparities in pregnancy-related morbidity and mortality of industrialized nations. Black, Indigenous and other people of color (BIPOC) patients have a 2-3 times higher risk of pregnancy-related mortality compared to white patients. For every maternal death, over 100 patients experience a severe maternal morbidity, which is a life-threatening complication during their delivery hospitalization, resulting in over 50,000 women and birthing people experiencing one of these events every year in the U.S. (with the majority occurring in BIPOC patients). These disparities are even more pronounced in the city of Philadelphia, the poorest of the nation's top ten largest cities. A recent report from the Philadelphia Maternal Mortality Review Committee identified 80% of mortalities were among BIPOC patients and 80% of those mortalities had identified social and structural barriers, including, but not limited to, mental health issues, substance use disorders and lack of prenatal care. Integrated bi-directional partnerships between birthing facilities, health care providers and community leaders and community birth support persons, such as doulas, is critical to improving health equity and maternal outcomes. While doulas and other community organizations partner with some birthing providers, the way in which this occurs is variable and the most effective model for integration through the pregnancy continuum has not been determined. Results from previous studies show the importance of implementing community models of care throughout the pregnancy continuum that will mitigate bias, mistrust, and mistreatment thereby improving both the experience and outcomes specifically and especially for Black birthing people.

The study will test the hypothesis that an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP) will mitigate bias and mistrust thereby improving both the experience and outcomes for Black birthing people at HUP. Within this study, the investigators will determine the effectiveness of this integrated partnership in reducing maternal depression score at 6 weeks postpartum. Self-efficacy, perceived trust of care providers, stress, birth satisfaction, and obstetric outcomes will also be assessed. Patients will be randomized (n=230) to Doula care (receive 2 prenatal visits, continuous intrapartum support, and 2 postpartum visits with a certified doula) or standard of care (receive prenatal care, labor and delivery, and postpartum care as they normally would if not in the study) and followed through 6 weeks postpartum.

研究设计

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

入排标准

年龄范围
16 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant patients who self-identify (as seen on Chart) as Black
  • Ages 16-55
  • Currently pregnant and in second trimester (gestational age between 13-30 weeks)
  • Plan to deliver at HUP
  • Patients must be able to read and understand English
  • Participants must be willing and able to sign the informed consent form

排除标准

  • Unable to provide written consent by being unable to read or sign informed consent.
  • PI Discretion

研究组 & 干预措施

Usual Care

No Intervention

Participants will continue to receive prenatal, labor and delivery, and postpartum care as they normally would if not in the study. Patients who seek doula services on their own will be allowed to do so

Doula Model of Care

Experimental

Participants will be offered to receive services by the certified doula. The doula will provide emotional support, prenatal support, intrapartum support and will facilitate the receipt of postpartum health care for the patient.

干预措施: Doula Model of Care (Other)

结局指标

主要结局

Edinburgh Postpartum Depression Scale (EPDS) score

时间窗: After delivery up to 6 weeks postpartum

Scores from the validated EPDS screening tool will be calculated using standard scoring criteria for each of the 10 items. A score of 9 or greater or indication of suicide ideation will be used to indicate a positive depression screen

次要结局

  • Obstetric outcomes: Mode of delivery(At delivery)
  • Obstetric outcomes: Preterm birth less than 37 weeks(At delivery)
  • Obstetric outcomes: Preterm birth less than 34 weeks(At delivery)
  • Self-efficacy(Post-randomization to 6 weeks postpartum)
  • Person centered prenatal care survey for people of color(After delivery up to 6 weeks postpartum)
  • Birth satisfaction (BSS-R survey)(After delivery up to 6 weeks postpartum)

研究者

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

Sindhu Srinivas, MD

Executive Director, Hospital of the University of Pennsylvania Cedar Avenue

University of Pennsylvania

研究点 (1)

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