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NCT03213509

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

Completed Results posted Last updated 17 October 2019
What this trial tests

trial testing Interview (Social and Verbal Autopsy) in Perinatal Death in 170 participants. Completed in 27 August 2017.

Timeline
3 July 2017
Primary endpoint
27 August 2017
27 August 2017

Quick facts

Lead sponsorHarvard School of Public Health (HSPH)
StatusCompleted
Study typeOBSERVATIONAL
Enrollment170
Start date3 July 2017
Primary completion27 August 2017
Estimated completion27 August 2017
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Harvard School of Public Health (HSPH)

Who can join

18 and older, any sex, with Perinatal Death or Neonatal Death. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cause of Death Primary · Early post-natal period (up to 7 days post-partum)

Cause of perinatal mortality

Stillbirth
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm20
Perinatal Death With Pause Point(s) Observed, Control Arm35
Early Neonatal Death
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm56
Perinatal Death With Pause Point(s) Observed, Control Arm50
Cause of Stillbirth Primary · Early post-natal period (up to 7 days post-partum)

Cause of Stillbirth

Obstructed Labor
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm3
Perinatal Death With Pause Point(s) Observed, Control Arm12
Other Specific Perinatal Cause
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm9
Perinatal Death With Pause Point(s) Observed, Control Arm9
Other Obstetric Complication
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm2
Perinatal Death With Pause Point(s) Observed, Control Arm4
Antepartum Hemorrhage
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm3
Perinatal Death With Pause Point(s) Observed, Control Arm3
Other
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm2
Perinatal Death With Pause Point(s) Observed, Control Arm3
Unknown
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm1
Perinatal Death With Pause Point(s) Observed, Control Arm4
Cause of Early Neonatal Death Primary · Early post-natal period (up to 7 days post-partum)

Cause of Early Neonatal Death

Perinatal Asphyxia
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm26
Perinatal Death With Pause Point(s) Observed, Control Arm26
Infection
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm13
Perinatal Death With Pause Point(s) Observed, Control Arm9
Pre-Term Birth Complications
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm8
Perinatal Death With Pause Point(s) Observed, Control Arm11
Other Specific Perinatal Cause
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm1
Perinatal Death With Pause Point(s) Observed, Control Arm2
Congenital Malformations
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm3
Perinatal Death With Pause Point(s) Observed, Control Arm0
Unknown
GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm5
Perinatal Death With Pause Point(s) Observed, Control Arm2
Sex of Babies Who Suffered Perinatal Mortality Secondary · Within 7 days postpartum

This measure refers to the sex of the babies who suffered a perinatal mortality, and whose mother/family member was interviewed about the death via verbal autopsy

GroupValue95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm41
Perinatal Death With Pause Point(s) Observed, Control Arm50
Perinatal Death With Pause Point(s) Observed, Intervention Arm35
Perinatal Death With Pause Point(s) Observed, Control Arm35

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Perinatal Death

Currently open trials in the same condition.

Other Harvard School of Public Health (HSPH) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03213509.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing