Trial Outcomes & Findings for A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia (NCT NCT00194987)
NCT ID: NCT00194987
Last Updated: 2018-11-07
Results Overview
this uses the birth platelet count of the fetuses from the study when they are born
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
102 participants
Primary outcome timeframe
32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40
Results posted on
2018-11-07
Participant Flow
pregnant women with a fetus affected by FNAIT were enrolled at multiple sites with local IRB permission and local consents fetuses were tracked in utero and after birth for 2 weeks
Participant milestones
| Measure |
Intravenous Gammglobulin (IVIG) 1g/kg Twice Per Week
51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.
premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was \< 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (\> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
|
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day
IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was \< 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be \> 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Intravenous Gammglobulin (IVIG) 1g/kg Twice Per Week
51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.
premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was \< 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (\> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
|
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day
IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was \< 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be \> 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Baseline characteristics by cohort
| Measure |
IVIG (Intravenous Gamma Globulin) 2g/kg/Week
n=51 Participants
pregnant women with alloimmune thrombocytopenia and a previous affected fetus/newborn and a current affected fetus starting IVIG 2 g/kg/week
|
IVIG 1g/kg/wk and Prednisone 0.5mg/kg/Day
n=51 Participants
pregnant women with alloimmune thrombocytopenia and a previous affected fetus/newborn and a current affected fetus starting IVIG 1 g/kg/week + prednisone 0.5mg/kg/day
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
46 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40this uses the birth platelet count of the fetuses from the study when they are born
Outcome measures
| Measure |
IVIG 1g/kg Twice Per Week
n=51 Participants
51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.
premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was \< 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (\> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
|
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day
n=51 Participants
IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was \< 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be \> 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
|
|---|---|---|
|
Number of Newborns With a Birth Platelet Count > 50,000/uL
|
48 number of newborns with >50,000 pets
|
47 number of newborns with >50,000 pets
|
SECONDARY outcome
Timeframe: time of ICH (range 20-40 wks)number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation
Outcome measures
| Measure |
IVIG 1g/kg Twice Per Week
n=51 Participants
51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.
premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was \< 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (\> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
|
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day
n=51 Participants
IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was \< 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be \> 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
|
|---|---|---|
|
Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study
|
0 number of newborns with ICH
|
0 number of newborns with ICH
|
SECONDARY outcome
Timeframe: 32 +/- 2 weeksNumber of Fetal Platelet Counts \> 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined
Outcome measures
| Measure |
IVIG 1g/kg Twice Per Week
n=51 Participants
51 women entered the study and received IVIG 1g/kg twice per week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout.
premeds were diphenhydramine, acetaminophen and single dose prednisone as needed if the fetal platelet count was \< 50,000/ul or not obtained at approximately 32 weeks of gestation either for technical reasons or parental refusal, prednisone 0.5mg/kg/day was added to the continued IVIG infusions delivery was primarily by Caesarean section unless the fetal count was known or strongly suspected to be (\> 50,000 all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and virtually all had parental incompatibility of HPA-1a ultrasound of the fetus was performed every 4 weeks or so and postnatally neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
|
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day
n=51 Participants
IVIG was infused at 1 gram/kg/week rounded off to the nearest 5-10 kg. The initial treatment weight was used throughout. premeds were diphenhydramine, acetaminophen and single dose prednisone as needed all women had fetal and neonatal alloimmune thrombocytopenia with a previous affected pregnancy and were known to be carrying an affected fetus treatment was initiated at approximately 20-26 weeks of gestation at approximately 32 weeks of gestation a fetal platelet count was obtained if the fetal platelet count was \< 50,000/ul or was not obtained for either technical difficulty or patient refusal, then a second 1g/kg/week of IVIG was added until delivery delivery was typically by C/S unless the fetal platelet count was known or strongly suspected to be \> 50,000/up neonatal platelet counts were obtained and treatment of the fetus with platelet transfusion and/or IVIG and/or steroids was given as needed as determined by the NICU staff where the baby was delivered
|
|---|---|---|
|
Number of Fetal Platelet Counts > 50,000/uL
|
44 number newborns with >50,000 pats
|
43 number newborns with >50,000 pats
|
Adverse Events
IVIG X 2 Weekly
Serious events: 14 serious events
Other events: 12 other events
Deaths: 0 deaths
IVIG 1 g/kg/wk + Prednisone
Serious events: 12 serious events
Other events: 8 other events
Deaths: 0 deaths
IVIG X 2 Weekly--fetuses/Newborns
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
IVIG x 1 + Prednisone---fetuses/Newborns
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IVIG X 2 Weekly
n=51 participants at risk
Intravenous Immunoglobulin (IVIG) one gram per kg bodyweight infused twice weekly to mothers during pregnancy
fetuses followed by serial ultrasound including after birth and newborns followed for 2 or so weeks after birth
|
IVIG 1 g/kg/wk + Prednisone
n=51 participants at risk
intravenous gammaglobulin 1 g/kg/wk infused once weekly to mother and prednisone 0.5 mg/kg/day taken by mothers during pregnancy and then tapered after birth fo newborn
fetuses followed by serial ultrasound including after birth and newborns followed for 2 or so weeks after birth
|
IVIG X 2 Weekly--fetuses/Newborns
n=51 participants at risk
fetuses and newborns of mother receiving IVIG x 2 weekly
|
IVIG x 1 + Prednisone---fetuses/Newborns
n=51 participants at risk
fetuses and newborns of mother receiving IVIG x 1 weekly + prednisone 0.5mg/kg daily
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
preterm labor
|
9.8%
5/51 • Number of events 5 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
3.9%
2/51 • Number of events 2 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Nervous system disorders
headache
|
7.8%
4/51 • Number of events 4 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
3.9%
2/51 • Number of events 2 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Infections and infestations
amnionitis
|
2.0%
1/51 • Number of events 1 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Endocrine disorders
gestational diabetes
|
3.9%
2/51 • Number of events 2 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
7.8%
4/51 • Number of events 4 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Pregnancy, puerperium and perinatal conditions
HELLP
|
2.0%
1/51 • Number of events 1 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Blood and lymphatic system disorders
thrombosis, venous
|
2.0%
1/51 • Number of events 1 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Psychiatric disorders
depression
|
2.0%
1/51 • Number of events 1 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
2.0%
1/51 • Number of events 1 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Endocrine disorders
diabetes mellitus
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
5.9%
3/51 • Number of events 3 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Nervous system disorders
fetal ICH
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Pregnancy, puerperium and perinatal conditions
premature delivery
|
7.8%
4/51 • Number of events 4 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
5.9%
3/51 • Number of events 3 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
7.8%
4/51 • Number of events 4 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
5.9%
3/51 • Number of events 3 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Infections and infestations
neonatal sepsis
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
Other adverse events
| Measure |
IVIG X 2 Weekly
n=51 participants at risk
Intravenous Immunoglobulin (IVIG) one gram per kg bodyweight infused twice weekly to mothers during pregnancy
fetuses followed by serial ultrasound including after birth and newborns followed for 2 or so weeks after birth
|
IVIG 1 g/kg/wk + Prednisone
n=51 participants at risk
intravenous gammaglobulin 1 g/kg/wk infused once weekly to mother and prednisone 0.5 mg/kg/day taken by mothers during pregnancy and then tapered after birth fo newborn
fetuses followed by serial ultrasound including after birth and newborns followed for 2 or so weeks after birth
|
IVIG X 2 Weekly--fetuses/Newborns
n=51 participants at risk
fetuses and newborns of mother receiving IVIG x 2 weekly
|
IVIG x 1 + Prednisone---fetuses/Newborns
n=51 participants at risk
fetuses and newborns of mother receiving IVIG x 1 weekly + prednisone 0.5mg/kg daily
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
jaw tightness
|
2.0%
1/51 • Number of events 1 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Product Issues
IVIG dose error
|
3.9%
2/51 • Number of events 2 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
3.9%
2/51 • Number of events 2 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Pregnancy, puerperium and perinatal conditions
hypertension
|
5.9%
3/51 • Number of events 3 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
3.9%
2/51 • Number of events 2 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Nervous system disorders
bells palsy
|
2.0%
1/51 • Number of events 1 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Nervous system disorders
headache
|
9.8%
5/51 • Number of events 5 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
3.9%
2/51 • Number of events 2 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Endocrine disorders
diabetes mellitus
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
3.9%
2/51 • Number of events 2 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
|
Endocrine disorders
neonatal hypoglycemia
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
0.00%
0/51 • collected for study women from 20 weeks of gestation until 2 weeks after birth of newborn fetus and newborns were collected for the same period of time
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place