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临床试验/NCT02165540
NCT02165540已完成不适用

The Impact of Doulas in the Surgical Management of Early Pregnancy Failure and Abortion Care

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2014年5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
75
试验地点
2
主要终点
The degree of physical discomfort reported by women during their MVA procedure.

研究概览

简要总结

The purpose of the study is to examine the impact of doula support for women undergoing a manual vacuum aspiration (MVA) for an early pregnancy failure or undesired pregnancy.

详细描述

As a means of providing emotional support and physical comfort for all pregnant women, doulas have emerged in recent years in the world of clinical abortion care. Traditionally, doulas are non-medical individuals trained to provide emotional support, pain management strategies, relaxation techniques, and information to pregnant women during labor. The positive impact of doulas on obstetrical health outcomes and patient satisfaction is well accepted.

Women with the support of a doula have been shown to have shorter labor, and rate birth as less difficult and more satisfying, than do mothers without doula support. They also report a greater ability to cope with labor and require less epidural and IV pain medication. In recent years, the term full spectrum doula has emerged to describe doulas who extend their supportive services to women at any stage of a pregnancy, including the management of a miscarriage or undesired pregnancy ending in abortion. The Doula Project, created in 2007 in New York City, and the Bay Area Doula Project, founded in 2011in San Francisco, were two of the first organized efforts to train doulas to provide abortion care and are now the largest in the United States. Scientific research on the impact of doulas during abortion and miscarriage management has been limited, but anecdotal reports from patients and providers suggest a positive impact on patient satisfaction. In this study we aim to test the impact of doulas on the physical, emotional, and overall experience among women undergoing a MVA for an early pregnancy failure or undesired pregnancy at the Penn Family Planning and Pregnancy Loss Center. We also aim to assess the impact of doula support from the medical assistants perception.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female 18 years or older who is choosing to have a surgical procedure for the management of early pregnancy failure or undesired pregnancy.
  • Pregnancy is not because of an incident of sexual assault or rape.

排除标准

  • Pregnancy is due to an incident of sexual assault or rape.

结局指标

主要结局

The degree of physical discomfort reported by women during their MVA procedure.

时间窗: At enrollment baseline

This data is obtained in-clinic via a brief questionnaire after the patient undergoes the MVA at enrollment baseline.

次要结局

  • The degree to which women sense empowerment before and following their MVA procedure(At enrollment baseline and 1-month follow-up)
  • A rating of the emotional response experienced by women before and after their MVA procedure.(At enrollment baseline and 1-month follow up)
  • The degree to which women are satisfied by their MVA procedure experience(At enrollment baseline and 1-month follow-up)
  • The degree to which women report the ability to emotionally cope with their MVA procedure.(At baseline visit and at 1-month follow-up)
  • The degree to which medical assistant reports a more positive or negative patient and personal experience with the MVA procedure(At enrollment baseline)

研究者

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

Courtney Schreiber

Assistant Professor, Obstetrics and Gynecology

University of Pennsylvania

研究点 (2)

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