Comparison · NCT04060667-fd595878
Intervention vs Control: Severe Maternal Outcome
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Intervention vs Control: Severe Maternal Outcome. Trial comparisons, record NCT04060667-fd595878. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04060667-fd595878
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0161 | 0.0109 | 0.0237 | wilson | |
| Risk in group 2 | 0.0153 | 0.0104 | 0.0224 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000855 | -0.00798 | 0.00987 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.609 | 1.83 | log | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.605 | 1.85 | log | |
| Number needed to treat, for one more participant with the outcome on Intervention than on Control | 1,170 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention | Wireless physiologic monitoring: The intervention in this study is the use of a wireless monitor to perform physiologic monitoring of women undergoing emergency cesarean delivery for the first 24 hours after completion of the cesarean and send alerts to responding clinicians should vital signs fall out of a pre-specified range. | 25 | 1,552 | OG000 |
| Group 2 | Control | Standard of Care | 25 | 1,639 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Severe Maternal Outcome
- Description
The primary effectiveness outcome was a composite measure of severe maternal morbidity (SMM) measured from enrollment until hospital discharge This composite measure is adapted from World Health Organization (WHO) near-miss morbidity criteria, as well as other severe maternal outcomes, including hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death.
- Time frame
- From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days
- Population
- Analysis was restricted to participants consenting for participation (intervention group) or with completed medical record review (control group)
Source ClinicalTrials.gov
Trial
- Title
- Wireless Physiologic Monitoring in Postpartum Women
- NCT number
- NCT04060667
- Phases
- NA
- Conditions
- Maternal Death During Childbirth, Pregnancy Complications
- Interventions
- Wireless physiologic monitoring
- Lead sponsor
- Massachusetts General Hospital
- Results first posted
- 2025-09-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04060667?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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