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 DeathPrimary· Early post-natal period (up to 7 days post-partum)
Cause of perinatal mortality
Stillbirth
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
20
Perinatal Death With Pause Point(s) Observed, Control Arm
35
Early Neonatal Death
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
56
Perinatal Death With Pause Point(s) Observed, Control Arm
50
Cause of StillbirthPrimary· Early post-natal period (up to 7 days post-partum)
Cause of Stillbirth
Obstructed Labor
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
3
Perinatal Death With Pause Point(s) Observed, Control Arm
12
Other Specific Perinatal Cause
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
9
Perinatal Death With Pause Point(s) Observed, Control Arm
9
Other Obstetric Complication
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
2
Perinatal Death With Pause Point(s) Observed, Control Arm
4
Antepartum Hemorrhage
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
3
Perinatal Death With Pause Point(s) Observed, Control Arm
3
Other
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
2
Perinatal Death With Pause Point(s) Observed, Control Arm
3
Unknown
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
1
Perinatal Death With Pause Point(s) Observed, Control Arm
4
Cause of Early Neonatal DeathPrimary· Early post-natal period (up to 7 days post-partum)
Cause of Early Neonatal Death
Perinatal Asphyxia
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
26
Perinatal Death With Pause Point(s) Observed, Control Arm
26
Infection
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
13
Perinatal Death With Pause Point(s) Observed, Control Arm
9
Pre-Term Birth Complications
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
8
Perinatal Death With Pause Point(s) Observed, Control Arm
11
Other Specific Perinatal Cause
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
1
Perinatal Death With Pause Point(s) Observed, Control Arm
2
Congenital Malformations
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
3
Perinatal Death With Pause Point(s) Observed, Control Arm
0
Unknown
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
5
Perinatal Death With Pause Point(s) Observed, Control Arm
2
Sex of Babies Who Suffered Perinatal MortalitySecondary· 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
Group
Value
95% CI
Perinatal Death With Pause Point(s) Observed, Intervention Arm
41
Perinatal Death With Pause Point(s) Observed, Control Arm
50
Perinatal Death With Pause Point(s) Observed, Intervention Arm
35
Perinatal Death With Pause Point(s) Observed, Control Arm
35
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.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Harvard School of Public Health (HSPH)
Last refreshed: 17 October 2019
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.