Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
NCT ID:
NCT01390233
Group ID:
EG002
Title:
Combined Urinary Catheter & Prepadil Gel
Description:
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
36
Other Number Affected:
0
Other Number At Risk:
36
Study:
NCT01390233
Results Section:
NCT01390233
Adverse Events Module:
NCT01390233