Trial Outcomes & Findings for Smart Discharges for Mom & Baby (NCT NCT05730387)
NCT ID: NCT05730387
Last Updated: 2025-04-10
Results Overview
Composite rate of maternal or neonatal death or re-admission within 6 weeks following delivery
Recruitment status
COMPLETED
Target enrollment
7182 participants
Primary outcome timeframe
6 weeks following delivery
Results posted on
2025-04-10
Participant Flow
Recruited women presenting for delivery at Jinja and Mbarara Regional Referral Hospitals in Uganda between March 2022 and August 2023 through a quasi-random sampling method. All women enrolled were followed up with, including those who delivered stillbirths or newborns who died in hospital.
Participant milestones
| Measure |
Phase I: Observational, Mothers
Mothers were recruited and enrolled from the two participating hospitals and those discharged alive were followed for 6 weeks post-discharge.
|
Phase I: Observational, Neonates
Data was collected for all births from the Phase I: Observational, Mothers enrolled in the study, including those that were stillbirths or otherwise dead before being discharged. Follow-up data was only collected for those discharged alive.
|
|---|---|---|
|
Overall Study
STARTED
|
7131
|
7359
|
|
Overall Study
Discharged
|
7129
|
6968
|
|
Overall Study
COMPLETED
|
7060
|
6891
|
|
Overall Study
NOT COMPLETED
|
71
|
468
|
Reasons for withdrawal
| Measure |
Phase I: Observational, Mothers
Mothers were recruited and enrolled from the two participating hospitals and those discharged alive were followed for 6 weeks post-discharge.
|
Phase I: Observational, Neonates
Data was collected for all births from the Phase I: Observational, Mothers enrolled in the study, including those that were stillbirths or otherwise dead before being discharged. Follow-up data was only collected for those discharged alive.
|
|---|---|---|
|
Overall Study
Stillbirth
|
0
|
262
|
|
Overall Study
Died during or after delivery
|
2
|
85
|
|
Overall Study
Died after being admitted
|
0
|
44
|
|
Overall Study
Lost to Follow-up
|
69
|
77
|
Baseline Characteristics
This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
Baseline characteristics by cohort
| Measure |
Phase I: Observational, Mother
n=7131 Participants
Mother enrolled from the two participating hospitals.
|
Phase I: Observational, Neonate
n=7359 Participants
Neonate enrolled after delivery including those that were stillbirths or died before being discharged.
|
Total
n=14490 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
n=7129 Participants • This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
|
—
|
26 years
n=7129 Participants • This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
|
|
Sex: Female, Male
Female
|
7131 Participants
n=7131 Participants • Neonates: 173 (2.35%) missing
|
3423 Participants
n=7186 Participants • Neonates: 173 (2.35%) missing
|
10554 Participants
n=14317 Participants • Neonates: 173 (2.35%) missing
|
|
Sex: Female, Male
Male
|
0 Participants
n=7131 Participants • Neonates: 173 (2.35%) missing
|
3763 Participants
n=7186 Participants • Neonates: 173 (2.35%) missing
|
3763 Participants
n=14317 Participants • Neonates: 173 (2.35%) missing
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Lives with the father of the baby
|
6439 Participants
n=7131 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
—
|
6439 Participants
n=7131 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
|
Education level
≤ P3
|
263 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
—
|
263 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
|
Education level
P4-P7
|
2263 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
—
|
2263 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
|
Education level
S1-S6
|
3200 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
—
|
3200 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
|
Education level
Post-secondary
|
1400 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
—
|
1400 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
|
Transport time
Less than 30 minutes
|
3414 Participants
n=7128 Participants • This measure only applies to mothers. Data for 3 participants (0.04%) is missing.
|
—
|
3414 Participants
n=7128 Participants • This measure only applies to mothers. Data for 3 participants (0.04%) is missing.
|
|
Transport time
30 minutes to 1 hour
|
2713 Participants
n=7128 Participants • This measure only applies to mothers. Data for 3 participants (0.04%) is missing.
|
—
|
2713 Participants
n=7128 Participants • This measure only applies to mothers. Data for 3 participants (0.04%) is missing.
|
|
Transport time
>1 hour
|
1001 Participants
n=7128 Participants • This measure only applies to mothers. Data for 3 participants (0.04%) is missing.
|
—
|
1001 Participants
n=7128 Participants • This measure only applies to mothers. Data for 3 participants (0.04%) is missing.
|
|
Had any children who have died
|
854 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
—
|
854 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
|
Socioeconomic Index Score
|
3 score on a scale
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
—
|
3 score on a scale
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
|
Household had sufficient food during pregnancy
|
1243 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
—
|
1243 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
|
Had admission vitals taken
|
7020 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
—
|
7020 Participants
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
|
Parity
|
2 pregnancies
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
—
|
2 pregnancies
n=7126 Participants • This measure only applies to mothers. Data for 5 participants (0.07%) is missing.
|
|
Diagnosed with chronic illness before pregnancy
|
865 Participants
n=7129 Participants • This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
|
—
|
865 Participants
n=7129 Participants • This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
|
|
Referral
|
3163 Participants
n=7128 Participants • This measure only applies to mothers. Data for 3 participants (0.04%) is missing.
|
—
|
3163 Participants
n=7128 Participants • This measure only applies to mothers. Data for 3 participants (0.04%) is missing.
|
|
Admitted to hospital during pregnancy
|
1002 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
—
|
1002 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
|
Number of antenatal care visits
<4
|
1862 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
—
|
1862 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
|
Number of antenatal care visits
4-8
|
5140 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
—
|
5140 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
|
Number of antenatal care visits
>8
|
125 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
—
|
125 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
|
Diagnosed with a pregnancy-related illness during pregnancy
|
4291 Participants
n=7131 Participants • This measure only applies to mothers.
|
—
|
4291 Participants
n=7131 Participants • This measure only applies to mothers.
|
|
Mode of Delivery
Vaginal
|
4546 Participants
n=7128 Participants • 3 (0.04%)
|
—
|
4546 Participants
n=7128 Participants • 3 (0.04%)
|
|
Mode of Delivery
Assisted vaginal
|
15 Participants
n=7128 Participants • 3 (0.04%)
|
—
|
15 Participants
n=7128 Participants • 3 (0.04%)
|
|
Mode of Delivery
Caesarean with labour
|
1995 Participants
n=7128 Participants • 3 (0.04%)
|
—
|
1995 Participants
n=7128 Participants • 3 (0.04%)
|
|
Mode of Delivery
Caesarean without labour
|
572 Participants
n=7128 Participants • 3 (0.04%)
|
—
|
572 Participants
n=7128 Participants • 3 (0.04%)
|
|
Surgical urgency of caesarean births
Immediate threat to woman or fetus
|
1246 Participants
n=2553 Participants • This measure only applies to mothers whose mode of delivery was caesarean. Data for 14 participants (0.55%) is missing.
|
—
|
1246 Participants
n=2553 Participants • This measure only applies to mothers whose mode of delivery was caesarean. Data for 14 participants (0.55%) is missing.
|
|
Surgical urgency of caesarean births
Maternal/fetal compromise but not immediately life threatening
|
877 Participants
n=2553 Participants • This measure only applies to mothers whose mode of delivery was caesarean. Data for 14 participants (0.55%) is missing.
|
—
|
877 Participants
n=2553 Participants • This measure only applies to mothers whose mode of delivery was caesarean. Data for 14 participants (0.55%) is missing.
|
|
Surgical urgency of caesarean births
Needs early delivery but no maternal/fetal compromise
|
30 Participants
n=2553 Participants • This measure only applies to mothers whose mode of delivery was caesarean. Data for 14 participants (0.55%) is missing.
|
—
|
30 Participants
n=2553 Participants • This measure only applies to mothers whose mode of delivery was caesarean. Data for 14 participants (0.55%) is missing.
|
|
Surgical urgency of caesarean births
At a time to suit the patient and maternity team
|
400 Participants
n=2553 Participants • This measure only applies to mothers whose mode of delivery was caesarean. Data for 14 participants (0.55%) is missing.
|
—
|
400 Participants
n=2553 Participants • This measure only applies to mothers whose mode of delivery was caesarean. Data for 14 participants (0.55%) is missing.
|
|
Resuscitation at birth
Not Resuscitated
|
4560 Participants
n=6702 Participants • This measure only applies to mothers. Data for 429 participants (6.02%) is missing.
|
—
|
4560 Participants
n=6702 Participants • This measure only applies to mothers. Data for 429 participants (6.02%) is missing.
|
|
Resuscitation at birth
Resuscitation with oxygen
|
265 Participants
n=6702 Participants • This measure only applies to mothers. Data for 429 participants (6.02%) is missing.
|
—
|
265 Participants
n=6702 Participants • This measure only applies to mothers. Data for 429 participants (6.02%) is missing.
|
|
Resuscitation at birth
Resuscitation without oxygen
|
1877 Participants
n=6702 Participants • This measure only applies to mothers. Data for 429 participants (6.02%) is missing.
|
—
|
1877 Participants
n=6702 Participants • This measure only applies to mothers. Data for 429 participants (6.02%) is missing.
|
|
Number of babies delivered
Individual
|
6907 Participants
n=7129 Participants • This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
|
—
|
6907 Participants
n=7129 Participants • This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
|
|
Number of babies delivered
Twin
|
217 Participants
n=7129 Participants • This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
|
—
|
217 Participants
n=7129 Participants • This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
|
|
Number of babies delivered
Triplet
|
5 Participants
n=7129 Participants • This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
|
—
|
5 Participants
n=7129 Participants • This measure only applies to mothers. Data for 2 participants (0.03%) is missing.
|
|
Mother admitted to higher care following delivery
|
570 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
—
|
570 Participants
n=7127 Participants • This measure only applies to mothers. Data for 4 participants (0.06%) is missing.
|
|
Birth Weight
|
—
|
3.1 kg
n=6915 Participants • This measure only applies to neonates. Data for 444 participants (6.03%) is missing. Missing neonate demographics include stillbirths and newborns who died in-hospital.
|
3.1 kg
n=6915 Participants • This measure only applies to neonates. Data for 444 participants (6.03%) is missing. Missing neonate demographics include stillbirths and newborns who died in-hospital.
|
|
Low birthweight (<2500g)
|
—
|
1038 Participants
n=6915 Participants • This measure only applies to neonates. Data for 444 participants (6.03%) is missing. Missing neonate demographics include stillbirths and newborns who died in-hospital
|
1038 Participants
n=6915 Participants • This measure only applies to neonates. Data for 444 participants (6.03%) is missing. Missing neonate demographics include stillbirths and newborns who died in-hospital
|
|
Length
|
—
|
49.5 cm
n=6821 Participants • This measure only applies to neonates. Data for 538 participants (7.31%) is missing. Missing neonate demographics include stillbirths and newborns who died in-hospital
|
49.5 cm
n=6821 Participants • This measure only applies to neonates. Data for 538 participants (7.31%) is missing. Missing neonate demographics include stillbirths and newborns who died in-hospital
|
|
Apgar at 1 minute
|
—
|
9 score
n=6918 Participants • This measure only applies to neonates. Data for 441 participants (5.99%) is missing. Missing neonate demographics include stillbirths and newborns who died in-hospital
|
9 score
n=6918 Participants • This measure only applies to neonates. Data for 441 participants (5.99%) is missing. Missing neonate demographics include stillbirths and newborns who died in-hospital
|
|
Apgar at 5 minutes
|
—
|
10 score
n=6918 Participants • This measure only applies to neonates. Data for 441 participants (5.99%) is missing. Missing neonate demographics include stillbirths and newborns who died in-hospital
|
10 score
n=6918 Participants • This measure only applies to neonates. Data for 441 participants (5.99%) is missing. Missing neonate demographics include stillbirths and newborns who died in-hospital
|
PRIMARY outcome
Timeframe: 6 weeks following deliveryComposite rate of maternal or neonatal death or re-admission within 6 weeks following delivery
Outcome measures
| Measure |
Phase I: Observational, Mother
n=7060 Participants
Mother enrolled from the two participating hospitals, survived to discharge and completed the 6-week follow-up
|
Phase I: Observational, Neonate
n=6891 Participants
Neonate enrolled after delivery, survived to discharge and completed the 6-week follow-up
|
|---|---|---|
|
Post-discharge Readmission or Mortality
|
231 Participants
|
349 Participants
|
SECONDARY outcome
Timeframe: 6 weeks following delivery% patients who reported attending at least one post-natal care visits within 6 weeks following delivery
Outcome measures
| Measure |
Phase I: Observational, Mother
n=7060 Participants
Mother enrolled from the two participating hospitals, survived to discharge and completed the 6-week follow-up
|
Phase I: Observational, Neonate
n=6968 Participants
Neonate enrolled after delivery, survived to discharge and completed the 6-week follow-up
|
|---|---|---|
|
Post-natal Care Visits
|
446 Participants
|
187 Participants
|
SECONDARY outcome
Timeframe: 6 weeks following delivery% of patients who reported seeking post-discharge care within 6 weeks following delivery
Outcome measures
| Measure |
Phase I: Observational, Mother
n=7060 Participants
Mother enrolled from the two participating hospitals, survived to discharge and completed the 6-week follow-up
|
Phase I: Observational, Neonate
n=6968 Participants
Neonate enrolled after delivery, survived to discharge and completed the 6-week follow-up
|
|---|---|---|
|
Post-discharge Health Seeking
Care seeking resulted in readmission
|
230 Participants
|
287 Participants
|
|
Post-discharge Health Seeking
Care seeking did not result in readmission
|
2637 Participants
|
1161 Participants
|
Adverse Events
Phase I: Observational, Mother
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Phase I: Observational, Neonate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 453 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Matthew O. Wiens
Institute for Global Health at BC Children's Hospital and BC Women's Hospital + Health Centre
Phone: 6048292562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place