Trial Outcomes & Findings for Verbal Autopsy of Maternal Deaths, Stillbirths, and Neonatal Deaths in BetterBirth (NCT NCT03213509)
NCT ID: NCT03213509
Last Updated: 2019-10-17
Results Overview
Cause of perinatal mortality
Recruitment status
COMPLETED
Target enrollment
170 participants
Primary outcome timeframe
Early post-natal period (up to 7 days post-partum)
Results posted on
2019-10-17
Participant Flow
Please note 170 cases were enrolled (ie, babies who suffered from perinatal mortality). Of these 170 cases, there were four sets of twins, both of whom died. This means that there were a total of 166 potential participants to interview via verbal autopsy (we asked for one interview in the case of twins).
Note: Perinatal mortality cases were assigned to intervention or control group based on their assignment during the BetterBirth Trial. This assignment did not impact the verbal autopsy data collection process; all cases underwent the same interview process.
Participant milestones
| Measure |
Participant Interviewed for Verbal Autopsy, Intervention Arm
Individual who was interviewed about a 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
|
Participant Interviewed for Verbal Autopsy, Control Arm
Individual who was interviewed about a 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
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
90
|
|
Overall Study
COMPLETED
|
76
|
85
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Participant Interviewed for Verbal Autopsy, Intervention Arm
Individual who was interviewed about a 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
|
Participant Interviewed for Verbal Autopsy, Control Arm
Individual who was interviewed about a 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
|
|---|---|---|
|
Overall Study
Did not consent for verbal autopsy
|
4
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participant Interviewed for Verbal Autopsy, Intervention Arm
n=74 Participants
Participant interviewed for verbal autopsy regarding a 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
|
Participant Interviewed for Verbal Autopsy, Control Arm
n=84 Participants
Participant interviewed for verbal autopsy regarding a 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
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=74 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=158 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=74 Participants
|
84 Participants
n=84 Participants
|
157 Participants
n=158 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=74 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=158 Participants
|
|
Age, Continuous
|
33 years
n=74 Participants
|
31 years
n=84 Participants
|
32 years
n=158 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=74 Participants
|
NA Participants
n=84 Participants
|
NA Participants
n=158 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=74 Participants
|
NA Participants
n=84 Participants
|
NA Participants
n=158 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
74 Participants
n=74 Participants
|
84 Participants
n=84 Participants
|
158 Participants
n=158 Participants
|
PRIMARY outcome
Timeframe: Early post-natal period (up to 7 days post-partum)Cause of perinatal mortality
Outcome measures
| Measure |
Perinatal Death With Pause Point(s) Observed, Intervention Arm
n=76 Participants
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
|
Perinatal Death With Pause Point(s) Observed, Control Arm
n=85 Participants
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
|
|---|---|---|
|
Cause of Death
Stillbirth
|
20 Participants
|
35 Participants
|
|
Cause of Death
Early Neonatal Death
|
56 Participants
|
50 Participants
|
PRIMARY outcome
Timeframe: Early post-natal period (up to 7 days post-partum)Cause of Stillbirth
Outcome measures
| Measure |
Perinatal Death With Pause Point(s) Observed, Intervention Arm
n=20 Participants
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
|
Perinatal Death With Pause Point(s) Observed, Control Arm
n=35 Participants
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
|
|---|---|---|
|
Cause of Stillbirth
Antepartum Hemorrhage
|
3 Participants
|
3 Participants
|
|
Cause of Stillbirth
Other
|
2 Participants
|
3 Participants
|
|
Cause of Stillbirth
Unknown
|
1 Participants
|
4 Participants
|
|
Cause of Stillbirth
Obstructed Labor
|
3 Participants
|
12 Participants
|
|
Cause of Stillbirth
Other Specific Perinatal Cause
|
9 Participants
|
9 Participants
|
|
Cause of Stillbirth
Other Obstetric Complication
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Early post-natal period (up to 7 days post-partum)Cause of Early Neonatal Death
Outcome measures
| Measure |
Perinatal Death With Pause Point(s) Observed, Intervention Arm
n=56 Participants
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
|
Perinatal Death With Pause Point(s) Observed, Control Arm
n=50 Participants
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
|
|---|---|---|
|
Cause of Early Neonatal Death
Perinatal Asphyxia
|
26 Participants
|
26 Participants
|
|
Cause of Early Neonatal Death
Infection
|
13 Participants
|
9 Participants
|
|
Cause of Early Neonatal Death
Pre-Term Birth Complications
|
8 Participants
|
11 Participants
|
|
Cause of Early Neonatal Death
Other Specific Perinatal Cause
|
1 Participants
|
2 Participants
|
|
Cause of Early Neonatal Death
Congenital Malformations
|
3 Participants
|
0 Participants
|
|
Cause of Early Neonatal Death
Unknown
|
5 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days postpartumThis 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
Outcome measures
| Measure |
Perinatal Death With Pause Point(s) Observed, Intervention Arm
n=76 Participants
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
|
Perinatal Death With Pause Point(s) Observed, Control Arm
n=85 Participants
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
|
|---|---|---|
|
Sex of Babies Who Suffered Perinatal Mortality
Male
|
41 Participants
|
50 Participants
|
|
Sex of Babies Who Suffered Perinatal Mortality
Female
|
35 Participants
|
35 Participants
|
Adverse Events
Interview (Social and Verbal Autopsy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place