Trial · NCT04060667
Wireless Physiologic Monitoring in Postpartum Women
NCT04060667, Not applicable, Completed, Massachusetts General Hospital; results first posted 2025-09-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Wireless Physiologic Monitoring in Postpartum Women. Trials, record NCT04060667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04060667
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Wireless Physiologic Monitoring in Postpartum Women
- NCT number
- NCT04060667
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 3,191 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Maternal Death During Childbirth, Pregnancy Complications
- Interventions
- Wireless physiologic monitoring
- First posted
- 2019-08-19
- Last updated
- 2026-07-23
- Results first posted
- 2025-09-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Severe Maternal Outcome | From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Severe Maternal Outcome | From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days | Analysis was restricted to participants consenting for participation (intervention group) or with completed medical record review (control group) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Severe Maternal Outcome | Intervention | 25 | participants | ||
| Severe Maternal Outcome | Control | 25 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention | 1,552 | |
| Overall Study | STARTED | Control | 1,639 | |
| Overall Study | COMPLETED | Intervention | 1,477 | |
| Overall Study | COMPLETED | Control | 1,629 | |
| Overall Study | NOT COMPLETED | Intervention | 75 | |
| Overall Study | NOT COMPLETED | Control | 10 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hysterectomy | Reproductive system and breast disorders | Intervention | 3 | 1,552 | 3 |
| serious | Hysterectomy | Reproductive system and breast disorders | Control | 6 | 1,629 | 6 |
| serious | Re-operation | Surgical and medical procedures | Intervention | 1 | 1,552 | 1 |
| serious | Re-operation | Surgical and medical procedures | Control | 2 | 1,629 | 2 |
| serious | ICU admission | Surgical and medical procedures | Intervention | 2 | 1,552 | 2 |
| serious | ICU admission | Surgical and medical procedures | Control | 3 | 1,629 | 3 |
| serious | cardiac arrest | Cardiac disorders | Intervention | 0 | 1,552 | 0 |
| serious | cardiac arrest | Cardiac disorders | Control | 1 | 1,629 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention | 3 | 1,552 |
| Total, all-cause mortality | Control | 1 | 1,629 |
| Total, other adverse events | Intervention | 0 | 1,552 |
| Total, other adverse events | Control | 0 | 1,629 |
| Total, serious adverse events | Intervention | 6 | 1,552 |
| Total, serious adverse events | Control | 12 | 1,629 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33579213 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K23HD097300 | Wireless Physiologic Monitoring in Postpartum Women in rural Uganda | BOATIN, ADELINE ADWOA | MASSACHUSETTS GENERAL HOSPITAL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2018 to 2022 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention vs Control: deaths from any cause | Trial comparisons |
| Intervention vs Control: Severe Maternal Outcome | Trial comparisons |
| Intervention vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04060667
GET https://conductscience.org/api/trials/v1/NCT04060667/registered