Adverse Events Module

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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

Ignite Creation Date: 2025-12-25 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT01601860
Description: Postpartum complication (Hemorrhage)
Frequency Threshold: 0
Time Frame: [Not specified]
Study: NCT01601860
Study Brief: The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Group Experimental: Intervention Group Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: Walking (with cervical dilation between 4 and 5 cm) Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) Shower (with dilation\> 7 cm); Use of non-pharmacological: Other: Non-pharmacological resources A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows: * Walking (with cervical dilation between 4 and 5 cm) * Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) * Shower (with dilation\> 7 cm); None None 0 40 0 40 View
Control Active Comparator: Control Group Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group. Other: Routine care: Other: Routine care Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient. None None 0 40 2 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Postpartum complication (Hemorrhage) * [1] NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions Other View