Study: NCT04258709

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 8 affected / 139 at risk

Adverse event: Fetal distress as indication for delivery via caesarean section
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 6 affected / 139 at risk

Adverse event: NICU admission during postpartum hospitalization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 13 affected / 139 at risk

Adverse event: Hyperbilirubinemia requiring phototherapy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 8 affected / 139 at risk

Adverse event: Reduced fetal movement during/after AME in past week
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 1 AME group participant was withdrawn by study staff after enrollment due to exclusion criteria upon EHR review.

This adverse event was only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 1 affected / 139 at risk

Adverse event: Rupture of membranes during AME
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 1 AME group participant was withdrawn by study staff after enrollment due to exclusion criteria upon EHR review.

This adverse event was only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 1 affected / 139 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 27 affected / 139 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 1 affected / 139 at risk

Adverse event: Iron transfusion required during postpartum hospitalization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 1 affected / 139 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 15 affected / 139 at risk

Adverse event: Infant participant requiring resuscitation beyond SDS after delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 3 affected / 139 at risk

Adverse event: Infant with hyperbilirubinemia requiring monitoring only
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 14 affected / 139 at risk

Adverse event: Infant with hypoglycemia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 8 affected / 139 at risk

Adverse event: Infant with clavicle fracture
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 1 affected / 139 at risk

Adverse event: Infant with NAS and prolonged hospitalization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 1 affected / 139 at risk

Adverse event: In-patient hospitalization (unrelated to AME)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participant admitted to hospital due to motor vehicle accident; 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 1 affected / 139 at risk

Adverse event: IUGR
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 2 affected / 139 at risk

Adverse event: Postpartum pre-E with SF
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 1 affected / 139 at risk

Adverse event: Oversupply at 2 weeks postpartum
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 4 participants (2 from each group) were withdrawn prior to the 2 week survey, either by self (n=1) or by staff (n=3) and thus were not followed to the 2 week timepoint
Frequency: 39 affected / 138 at risk

Adverse event: Delivery prior to 39 weeks
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 4 participants (2 from each group) were withdrawn prior to 39 weeks gestation, either by self (n=1) or by staff (n=3)
Frequency: 39 affected / 138 at risk

Adverse event: Lactogenesis II onset < 2 days or > 4 days postpartum or no onset
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 4 participants (2 from each group) were withdrawn prior to the 2 week survey, either by self (n=1) or by staff (n=3) and thus were not followed to the 2 week timepoint
Frequency: 39 affected / 138 at risk

Adverse event: Participant reported emotional discomfort or anxiety with AME while on AME interventionist call
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 8 affected / 138 at risk

Adverse event: Participant reported hand fatigue/pain/discomfort with AME while on AME interventionist call
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 6 affected / 138 at risk

Adverse event: Participant reported breast/nipple discomfort associated with AME while on AME interventionist call
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 7 affected / 138 at risk

Adverse event: Participant reported breast or nipple pain or soreness via daily text diaries
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 32 affected / 138 at risk

Adverse event: Participant reported hand fatigue/hand cramping via daily text message diaries
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 25 affected / 138 at risk

Adverse event: Participant reported anxiety/uneasiness/embarrassment via daily text message diaries
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 16 affected / 138 at risk

Adverse event: Participant reported cramping via daily text message diary
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 2 affected / 138 at risk

Adverse event: Participant reported pelvic pain during daily text message diaries
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 1 affected / 138 at risk

Adverse event: Participant reported lightheadedness/nausea during expression via daily text message diary
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 1 affected / 138 at risk

Adverse event: Participant reported no/little milk output via daily text message diaries
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME
Frequency: 4 affected / 138 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 13 affected / 139 at risk

Adverse event: Fetal distress as indication for delivery via caesarean section
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 9 affected / 139 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 1 affected / 139 at risk

Adverse event: NICU admission during postpartum hospitalization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 13 affected / 139 at risk

Adverse event: Hyperbilirubinemia requiring phototherapy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 5 affected / 139 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 14 affected / 139 at risk

Adverse event: Polyhydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 2 affected / 139 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 3 affected / 139 at risk

Adverse event: Partial placental abruption
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 2 affected / 139 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 11 affected / 139 at risk

Adverse event: Infant participant requiring resuscitation beyond SDS after delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 7 affected / 139 at risk

Adverse event: Infant with hyperbilirubinemia requiring monitoring only
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 9 affected / 139 at risk

Adverse event: Infant with hypoglycemia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 6 affected / 139 at risk

Adverse event: Infant with hip dysplasia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review.
Frequency: 1 affected / 139 at risk

Adverse event: Oversupply at 2 weeks postpartum
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 4 participants (2 from each group) were withdrawn prior to the 2 week survey, either by self (n=1) or by staff (n=3) and thus were not followed to the 2 week timepoint
Frequency: 21 affected / 138 at risk

Adverse event: Delivery prior to 39 weeks
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 4 participants (2 from each group) were withdrawn prior to 39 weeks gestation, either by self (n=1) or by staff (n=3)
Frequency: 31 affected / 138 at risk

Adverse event: Lactogenesis II onset < 2 days or > 4 days postpartum or no onset
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Please note that 4 participants (2 from each group) were withdrawn prior to the 2 week survey, either by self (n=1) or by staff (n=3) and thus were not followed to the 2 week timepoint
Frequency: 41 affected / 138 at risk