Comparison · NCT04598165-sae
Interactive Two-way SMS Dialogue vs No SMS Control: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Interactive Two-way SMS Dialogue vs No SMS Control: serious adverse events. Trial comparisons, record NCT04598165-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04598165-sae
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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 | 0.0683 | 0.059 | 0.0788 | wilson | |
| Risk in group 2 | 0.0455 | 0.038 | 0.0543 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0228 | 0.01 | 0.0357 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 1.19 | 1.89 | log | |
| Odds ratio, group 1 over group 2 | 1.54 | 1.21 | 1.96 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Interactive Two-way SMS Dialogue than on No SMS Control | 43.8 | 28 | 99.9 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Interactive Two-way SMS Dialogue | Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.~Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support. | 171 | 2,505 | EG000 |
| Group 2 | No SMS Control | Control receiving standard of care. | 114 | 2,508 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Source ClinicalTrials.gov
Trial
- Title
- Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
- NCT number
- NCT04598165
- Phases
- NA
- Conditions
- Neonatal Death, Perinatal Death, Depression
- Interventions
- Interactive two-way SMS dialogue
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Results first posted
- 2024-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04598165?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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