Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intervention Arm: Weekly IP3 Text Messages | * A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation. * Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers. * Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information * Formal letter of encouragement from provider at 28 weeks gestation Intervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3. | 0 | None | 0 | 14 | 0 | 14 | View |
| Control Arm: General Pregnancy Text Messages | * a pre-intervention questionnaire * a narrated powerpoint with general information about the clinic * a post-presentation questionnaire * text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple) * an exit interview Active Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information. | 0 | None | 0 | 16 | 0 | 16 | View |