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 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
NCT ID:
NCT04021602
Group ID:
EG000
Title:
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
Description:
Participants randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions, one breastfeeding session, and participation in a professional peer support group. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support, followed by 6 DPP sessions.
DPP: Phase 1 consists of 16 sessions during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions. Phase 2 (post-core) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum.
Breastfeeding: Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
Usual Care: Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
9
Other Number Affected:
0
Other Number At Risk:
9
Study:
NCT04021602
Results Section:
NCT04021602
Adverse Events Module:
NCT04021602