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临床试验/NCT07157059
NCT07157059已完成不适用

Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Perceptions of Provider Communication

研究概览

简要总结

The study was done to learn how doula-enhanced care provided to Black birthing people improved perceived communication and quality care.

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 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Black birthing people
  • Received care and plan to delivery at the University of Kansas Medical Center
  • Scored positive to social determinants of health screener
  • Gestational age between 14-27.6 weeks at enrollment

排除标准

  • Pregnancy not viable or pregnancy not intrauterine on ultrasound
  • Patients who are not willing to be randomized into not receiving doula enhanced
  • Patients who do not plan to delivery at the University of Kansas Health System
  • Non-Black birthing people.
  • Planned cesarean section
  • Patients with a known major fetal anomaly
  • Non-English speaking

研究组 & 干预措施

Doula-Enhanced Care Group

Experimental

This group received doula-enhanced care along with routine pregnancy care.

干预措施: Doula Care (Behavioral)

Routine Pregnancy Care Group

No Intervention

This group received routine pregnancy care.

结局指标

主要结局

Perceptions of Provider Communication

时间窗: Study enrollment through 6-weeks postpartum

Assess patient's perception of their quality of communication with their provider using a Likert scale survey (ie. did the patient feel comfortable asking their prenatal provider questions regarding their health, did the patient feel listened to by their provider. Survey scale was 1 to 5 and correlated with agreement or disagreement. Reporting Likert's mean score as surveys were collected at three study timepoints (1. Baseline at study enrollment, 2. Immediate postdelivery, 3. 6-weeks postpartum); higher mean scores indicated more responses in disagreement.

Perceptions of Maternal Care

时间窗: Study enrollment through 6-weeks postpartum

Assess patient's perceptions of maternal care using a Likert scale survey (i.e. their physician spending time with the patient talking to them about their labor and delivery expectations) Survey scale was 1 to 5 and correlated with agreement or disagreement. Reporting Likert's mean score as surveys were collected at three study timepoints (1. Baseline at study enrollment, 2. Immediately post-delivery, 3. 6-weeks postpartum); higher mean scores indicated more responses in disagreement.

次要结局

  • Neonatal Morbidity(Birth through 6-weeks postpartum)
  • Perinatal Outcome - Gestational Age (GA) at Delivery(14-28 weeks GA through delivery)
  • Perinatal Outcome - Number of Participants With Preterm <37 Weeks Births(14-28 weeks GA through delivery)
  • Perinatal Outcome - Number of Participants With Cesarean Sections(14-28 weeks GA through delivery)
  • Perinatal Outcome - Number of Participants With Gestational Hypertension/Preeclampsia(14-28 weeks GA through delivery)
  • Neonatal Morbidity(Birth/delivery)
  • Antepartum Depression(Study enrollment through delivery)
  • Postpartum Depression(Birth (delivery) through 6-weeks postpartum)
  • Maternal Pain Management(Delivery through hospital discharge)
  • Lactation Status - Number of Participants Lactating and Breastfeeding(Birth)
  • Lactation Status - Number of Participants Lactating and Breastfeeding After L&D Discharge(Birth through 6-weeks postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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