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 @ 4:02 AM
Ignite Modification Date: 2025-12-26 @ 2:55 AM
NCT ID: NCT04021602
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected from the time of enrollment through 6 months postpartum follow up.
Study: NCT04021602
Study Brief: Diabetes Prevention Program Feasibility Study of Breastfeeding
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 1 (Tx1) - DPP + Breastfeeding + Usual Care 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. 0 None 1 9 0 9 View
Intervention 2 (Tx2) - DPP Only + Usual Care Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions. At delivery, the patient will receive usual lactation support in the hospital, 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. 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. 0 None 0 14 0 14 View
Intervention 3 (Tx3) - Usual Care Only Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital. 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. 0 None 1 12 0 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Miscarriage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):