Stillbirth Clinical Trial
Official title:
Verbal Autopsy of Maternal Deaths, Stillbirths, and Neonatal Deaths in BetterBirth
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.
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.)
Data will be collected using the WHO standard tools for conducting stillbirth or neonatal
verbal autopsies, modified for the local context. A section on social autopsy will also be
incorporated in the existing study instrument. These tools are standardized and adapted to
use in these settings and have been implemented before in other studies in similar
communities in U.P. (example: "AMANHI" and "Impact of topical application of cold-pressed
sunflower seed oil with improved massage practices on neonatal mortality: a cluster
randomized controlled trial in rural North India"). A team of specially trained data
collectors (given the sensitive nature of the verbal autopsy questionnaire) will collect the
data on existing Android based data collection platform.
Data will be collected by specially trained data collectors. They will collect the data at
participants' homes. Participants will include the mother (in case of neonatal death) and any
additional person who was present during the events that led to the death. Additional
interviewees may include the delivered mother's husband, mother, mother-in-law, other family
member, neighbor, etc. The delivered mother will be asked which individuals, if any, should
be included in the interview. The mother and the individuals they indicate will be consented
individually but interviewed together.
Each interview will take approximately 60 minutes.
A team of specially trained data collectors will be hired. Data will be collected on tablets
using a data collection platform that has in-built checks of missing values, range checks,
skip patterns etc. to minimize the error in data collection. A GPS monitoring of location of
interview will be conducted. The data will be checked at an aggregate level for heaping,
interviewer-specific patterns, etc. Forms identified with errors will be sent back for
verification and re-entry, but audit-trail will be captured to ensure that the full trail
from original data and changes will be maintained with timestamp, GPS and user information.
On-site quality assurance would involve both real-time data checks as well as GPS
verification of the location of data collection. Data access will be restricted by users,
with different privileges for data collectors, supervisors and study investigators. All
personal identification information including names, etc. will be encrypted, and only a
unique identification number to identify individuals will be made available for analysis.
Data will be hosted over a secured network.
Every case will be coded for assigning underlying cause of death, antecedent causes and
timing of death by trained and certified physicians. A WHO standard software and coding
protocol will be used by these physicians to assign causes of death. The data collected
through tablets will be sent to the central server. The narratives of every case will be
collected on paper and a scan of the narrative will be sent along with the data. This entire
data will be uploaded on the physician coding software from which the verbal autopsy cases
will be allotted to physicians for coding. Each case will be independently coded by two
physicians and in case of mismatch in the underlying cause of death between the two
physicians, a third physician will independently code for the cause of death. Finally, if
none of the three underlying causes of death match, a higher level physician arbitrator will
resolve the case - this will be done to minimize unclassified deaths. A physician
coordinator, who has extensive prior experience of coding verbal autopsy data will oversee
the entire process and resolve issues with the help of supervisors of the data collection
team. All the cases will be de-identified before uploading on the software for coding.
The verbal autopsy findings will be helpful to understand the result of the BetterBirth
Trial. In addition, the findings will inform future investigations of maternal and newborn
harm, especially those further upstream in health system and policy design.
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