Trial Outcomes & Findings for A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome (NCT NCT00201643)
NCT ID: NCT00201643
Last Updated: 2015-01-07
Results Overview
This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at \< 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
437 participants
Primary outcome timeframe
From birth to 28 days of life
Results posted on
2015-01-07
Participant Flow
Pregnant women were recruited at 18 private (15) and university (3) medical centers from May 2003 through February 2008.
no washout, run-in or transition events occurred between enrollment and group assignment.
Participant milestones
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
214
|
|
Overall Study
COMPLETED
|
218
|
210
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
Baseline Characteristics
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
Baseline characteristics by cohort
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=223 Participants
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=214 Participants
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
Total
n=437 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
|
223 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
437 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 6 • n=5 Participants
|
29 years
STANDARD_DEVIATION 6 • n=7 Participants
|
29 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
223 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
437 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
|
223 participants
n=5 Participants
|
214 participants
n=7 Participants
|
437 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From birth to 28 days of lifePopulation: This was an intent to treat protocol. In patients delivering before 34 weeks we estimated that the sample size of at least 217 subjects in each arm would be needed to have 80% power to detect a 40% reduction in neonatal morbidity (to 16.8%).
This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at \< 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death
Outcome measures
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=163 Participants
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=165 Participants
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.
|
71 participants
|
105 participants
|
SECONDARY outcome
Timeframe: gestational age at delivery in weeks of gestationPopulation: Modified intent to treat
Reported the average/mean Neonatal gestational age (GA) (reported in weeks of pregnancy) at the time of birth for both groups (ACS vs. Placebo).
Outcome measures
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=223 Participants
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=214 Participants
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Gestational Age at (@) Delivery
|
33.1 Weeks
Standard Deviation 3.1
|
33.0 Weeks
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: At time of BirthPopulation: Intent to treat protocol
Measured mean Birth weights of Neonates in each arm as reported in grams on the birth record.
Outcome measures
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=223 Participants
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=214 Participants
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Neonatal Birth Weight Reported in Grams
|
1905 grams
Standard Deviation 738
|
1920 grams
Standard Deviation 667
|
SECONDARY outcome
Timeframe: Measured at birth.Population: Intent to Treat
Noted as the total number of Neonates delivering at \< 34 weeks gestation for which their weights fell within the 10th percentile at time of birth.
Outcome measures
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=162 Participants
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=161 Participants
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation.
|
25 paticipants
|
20 paticipants
|
SECONDARY outcome
Timeframe: BirthPopulation: Intent to treat
Reported as the average of all neonatal head circumferences (HC) taken at time of birth in each group.
Outcome measures
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=223 Participants
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=214 Participants
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Neonatal Head Circumference Taken at Time of Birth.
|
30.2 centemeters (cm)
Standard Deviation 3.0
|
30.0 centemeters (cm)
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: birth to 28 days of lifePopulation: Intent to treat (ITT)
The number of babies who required ventilatory support within the first 28 days of life. Equal to or great than 12 hours was considered one day.
Outcome measures
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=267 Participants
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=273 Participants
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life.
|
70 participants
|
95 participants
|
SECONDARY outcome
Timeframe: Birth to 28 days of lifePopulation: ITT
The Number of neonates who required surfactant therapy within the first 28 days after birth.
Outcome measures
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=273 Participants
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=280 Participants
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Number of Neonates Who Required Surfactant Therapy After Birth.
|
70 participant
|
99 participant
|
SECONDARY outcome
Timeframe: birth to 28 days of lifePopulation: ITT
Total number of neonates with pneumothorax diagnosed postpartum.
Outcome measures
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=275 Participants
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=281 Participants
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Number of Neonates With Pneumothorax
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Up to 28 days after giving birthPopulation: ITT
Total number of Mothers having Maternal infectious morbidity (e.g. endometritis \& maternal sepsis) noted from birth through 28 days after birth
Outcome measures
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=223 Participants
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=214 Participants
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Maternal Infectious Morbidity.
|
8 participants
|
10 participants
|
Adverse Events
"Rescue" Course of Betamethasone or Dexamethasone
Serious events: 40 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Normal Saline)
Serious events: 41 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
"Rescue" Course of Betamethasone or Dexamethasone
n=512 participants at risk
Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
|
Placebo (Normal Saline)
n=502 participants at risk
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.
The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Congenital Defect
|
2.8%
8/289 • Number of events 10 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
4.2%
12/288 • Number of events 13 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Blood and lymphatic system disorders
Anemia
|
0.39%
2/512 • Number of events 2 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.20%
1/502 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Blood and lymphatic system disorders
DIC
|
0.00%
0/512 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.20%
1/502 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Cardiac disorders
Aortic Stenosis
|
0.35%
1/289 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.35%
1/288 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Cardiac disorders
Cardiac Dysfunction
|
1.7%
5/289 • Number of events 5 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.69%
2/288 • Number of events 2 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Gastrointestinal disorders
NEC
|
0.69%
2/289 • Number of events 2 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
1.7%
5/288 • Number of events 5 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Gastrointestinal disorders
Small Bowel Rotation
|
0.00%
0/289 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.35%
1/288 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Hepatobiliary disorders
Hyperbilirubenemia
|
0.69%
2/289 • Number of events 2 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.35%
1/288 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Hepatobiliary disorders
Hepatosplenomegally
|
0.00%
0/289 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.35%
1/288 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Infections and infestations
Wound infections
|
1.8%
4/223 • Number of events 4 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
1.4%
3/214 • Number of events 3 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Infections and infestations
Sepsis
|
0.69%
2/289 • Number of events 2 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
1.0%
3/288 • Number of events 3 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Infections and infestations
Mastitis
|
0.00%
0/223 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.47%
1/214 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Injury, poisoning and procedural complications
Post delivery/C/S hemorrage
|
1.8%
4/223 • Number of events 4 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
1.9%
4/214 • Number of events 4 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Injury, poisoning and procedural complications
Spinal Headache
|
0.45%
1/223 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.00%
0/214 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Injury, poisoning and procedural complications
soft tissue rectal mass
|
0.00%
0/289 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.35%
1/288 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Injury, poisoning and procedural complications
Intraoperative Bladder Tear
|
0.00%
0/223 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.47%
1/214 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Nervous system disorders
PVL
|
0.35%
1/289 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.00%
0/288 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Pregnancy, puerperium and perinatal conditions
Intraventicular Hemorrage (Grade III, IV)
|
0.69%
2/289 • Number of events 2 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
1.0%
3/288 • Number of events 3 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Pregnancy, puerperium and perinatal conditions
Perinatal fetal demise
|
0.69%
2/289 • Number of events 2 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.35%
1/288 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Surgical and medical procedures
D & C for retained products
|
0.45%
1/223 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.47%
1/214 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Pregnancy, puerperium and perinatal conditions
Abruption
|
0.00%
0/223 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
1.4%
3/214 • Number of events 3 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Respiratory, thoracic and mediastinal disorders
Apnea/respiratory distress
|
0.35%
1/289 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
1.0%
3/288 • Number of events 3 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Disease
|
0.69%
2/289 • Number of events 2 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.00%
0/288 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/223 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.47%
1/214 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Gastrointestinal disorders
Ruptured Appendix
|
0.00%
0/223 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.47%
1/214 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/512 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
0.20%
1/502 • Number of events 1 • 4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge. The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm \& 288=placebo * maternal event N 223=test arm \& 214=placebo * maternal \& neonatal 512= test arm \& 502=placebo
|
Other adverse events
Adverse event data not reported
Additional Information
Kimberly A. Maurel, MSN, CNS
Obstetrix Medical Group, Inc.
Phone: 714-593-9171
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60