Verbal Autopsy of Maternal Deaths, Stillbirths, and Neonatal Deaths in BetterBirth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Cause of Death
研究概览
简要总结
The purpose of this study is to conduct Verbal Autopsies of deaths ( stillbirths and neonatal deaths together) identified in the BetterBirth trial to identify their potential causes, timing, and social determinants.
详细描述
In order to be included in this study, one must be the mother or family member of an individual who was enrolled in the BetterBirth Trial and died. Women who did not consent to follow-up in the BetterBirth study will be excluded.
We identified these families by using data from the BetterBirth Trial, in which there was a perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch. Our analyses focus on data surrounding the perinatal deaths.
Respondents for the neonatal deaths and stillbirths include mother or the family members of the baby. Mothers had consented to follow-up as part of the BetterBirth Trial.
These individuals will be initially contacted by telephone. Individuals will be asked to participate in verbal autopsy, and, if they agree, a date and time for the interview will be determined. A data collector from CEL or PSI will visit the participant's home on an agreed-upon date and written consent will be obtained. In the event that participants cannot be reached by phone, study staff members will attempt to make contact via Accredited Social Health Activists (ASHAs), who are appointed by the National Rural Health Mission and act as conduits between patients and the health system. The data collector will attempt to call the relevant ASHA worker and request her assistance in establishing contact with the mother. The ASHA will be asked to provide a telephone number at which the mother can be reached, if possible.
Final attempts at contact will be made via home visit if participants cannot be reached either via telephone or with ASHA engagement. Individuals who are reached at home will be introduced to the study and asked to participate using the appropriate recruitment script. For those individuals who agree to participate, data collectors will schedule a time to return to participants' homes for interviews to be conducted. (Note: Home visits are a culturally acceptable practice in this context; for example, home visits were used in the BetterBirth Trial for collection of 7-day outcomes of mothers and newborns.)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother, family members, and community members of deceased babies who enrolled in the BetterBirth Trial
排除标准
- •Mothers and family members members who did not consent to follow-up in the BetterBirth Trial
结局指标
主要结局
Cause of Death
时间窗: Early post-natal period (up to 7 days post-partum)
Cause of perinatal mortality
Cause of Stillbirth
时间窗: Early post-natal period (up to 7 days post-partum)
Cause of Stillbirth
Cause of Early Neonatal Death
时间窗: Early post-natal period (up to 7 days post-partum)
Cause of Early Neonatal Death
次要结局
未报告次要终点
研究者
Atul Gawande
Principal Investigator
Harvard School of Public Health (HSPH)
