Verbal Autopsy of Maternal Deaths, Stillbirths, and Neonatal Deaths in BetterBirth

NCT03213509 | Completed Results

• 1 other identifier: OPP1017378
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perinatal Death; Neonatal Death; Stillbirth

Outcome Measures

Primary Outcomes (3)

• Cause of Death

  Cause of perinatal mortality

  Early post-natal period (up to 7 days post-partum)

• Cause of Stillbirth

  Cause of Stillbirth

  Early post-natal period (up to 7 days post-partum)

• Cause of Early Neonatal Death

  Cause of Early Neonatal Death

  Early post-natal period (up to 7 days post-partum)

Other Outcomes (1)

• Sex of Babies Who Suffered Perinatal Mortality

  Within 7 days postpartum

Study Arms (2)

Perinatal Death With Pause Point(s) Observed, Intervention Arm

Any perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch, in the intervention arm of the BetterBirth Trial. The study involves administering verbal and social autopsies to the mother or family member of a baby who is in this cohort.

Other: Interview (Social and Verbal Autopsy)

Perinatal Death With Pause Point(s) Observed, Control Arm

Any perinatal death where one or more pause points was observed by BetterBirth staff (FADA) at 2 months or 6 months post-intervention launch, in the control arm of the BetterBirth Trial. The study involves administering verbal and social autopsies to the mother or family member of a baby who is in this cohort.

Other: Interview (Social and Verbal Autopsy)

Interventions

Interview (Social and Verbal Autopsy) OTHER

Verbal autopsy is a technique used to determine the cause of death by asking caregivers, friends or family members about signs and symptoms exhibited by the deceased in the period before death. This is usually done using a standardized questionnaire that collects details on signs, symptoms, complaints and any medical history or events. The cause of death, or the sequence of causes that led to death, are assigned based on the data collected by this questionnaire and on any other available information. The social autopsy tool is used in conjunction with the verbal autopsy tool to explore the non-biological factors contributing to a death, including the social, behavioural and health systems determinants of maternal and child deaths.

Perinatal Death With Pause Point(s) Observed, Control Arm; Perinatal Death With Pause Point(s) Observed, Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Respondents for the neonatal deaths and stillbirths include mother, family members, or community members of the baby. Mothers had consented to follow-up as part of the BetterBirth Trial.

You may qualify if:

• Mother, family members, and community members of deceased babies who enrolled in the BetterBirth Trial

You may not qualify if:

• Mothers and family members members who did not consent to follow-up in the BetterBirth Trial

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Community Empowerment Lab: collaborator
• Population Services International: collaborator

Study Sites (1)

Community Empowerment Labs

Shivgarh, Uttar Pradesh, 229308, India

Location

MeSH Terms

Conditions

Perinatal Death; Stillbirth

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Death

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Katherine Semrau
• Organization: Ariadne Labs

betterbirth@ariadnelabs.org

617-384-6555

Study Officials

• Katherine Semrau, PhD

  Ariadne Labs

  PRINCIPAL INVESTIGATOR

• Vishwajeet Kumar

  Community Empowerment Lab

  PRINCIPAL INVESTIGATOR

• Arti Kumar

  Community Empowerment Lab

  PRINCIPAL INVESTIGATOR

• Atul Gawande, MD, MPH

  Ariadne Labs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: July 3, 2017
• Primary Completion: August 27, 2017
• Study Completion: August 27, 2017
• Last Updated: October 17, 2019
• Results First Posted: June 5, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)