Trial Outcomes & Findings for RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix (NCT NCT00439374)
NCT ID: NCT00439374
Last Updated: 2019-07-15
Results Overview
Number of participants delivering before 37 weeks gestation by indication
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
657 participants
Primary outcome timeframe
Delivery before 37 weeks gestation
Results posted on
2019-07-15
Participant Flow
From April 2007 through May 2011, the fourteen centers of the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development participated in this randomized double-blind placebo-controlled trial. Eligible women were offered participation.
Women who signed informed consent received a "compliance" injection of the placebo and were asked to return at least 3 days later for randomization. If a woman did not return for a randomization visit before 23 weeks 0 days of gestation, she was excluded.
Participant milestones
| Measure |
17 Alpha-hydroxyprogesterone Caproate
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
castor oil
|
|---|---|---|
|
Overall Study
STARTED
|
327
|
330
|
|
Overall Study
COMPLETED
|
327
|
330
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Includes only the patients that had a cervical funnel present.
Baseline characteristics by cohort
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
Total
n=657 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.8 years
STANDARD_DEVIATION 5.3 • n=327 Participants
|
21.6 years
STANDARD_DEVIATION 4.4 • n=330 Participants
|
22.2 years
STANDARD_DEVIATION 4.9 • n=657 Participants
|
|
Sex: Female, Male
Female
|
327 Participants
n=327 Participants
|
330 Participants
n=330 Participants
|
657 Participants
n=657 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=327 Participants
|
0 Participants
n=330 Participants
|
0 Participants
n=657 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic white
|
76 Participants
n=327 Participants
|
74 Participants
n=330 Participants
|
150 Participants
n=657 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic black
|
179 Participants
n=327 Participants
|
161 Participants
n=330 Participants
|
340 Participants
n=657 Participants
|
|
Race/Ethnicity, Customized
Hispanic white
|
19 Participants
n=327 Participants
|
38 Participants
n=330 Participants
|
57 Participants
n=657 Participants
|
|
Race/Ethnicity, Customized
Hispanic black
|
2 Participants
n=327 Participants
|
0 Participants
n=330 Participants
|
2 Participants
n=657 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=327 Participants
|
3 Participants
n=330 Participants
|
7 Participants
n=657 Participants
|
|
Race/Ethnicity, Customized
Other
|
47 Participants
n=327 Participants
|
54 Participants
n=330 Participants
|
101 Participants
n=657 Participants
|
|
Prepregnancy body mass index
|
26.1 kg^m2
STANDARD_DEVIATION 6.9 • n=327 Participants
|
25.4 kg^m2
STANDARD_DEVIATION 6.5 • n=330 Participants
|
25.7 kg^m2
STANDARD_DEVIATION 6.7 • n=657 Participants
|
|
Prior Pregnancy
<13 wk of gestation
|
92 Participants
n=327 Participants
|
82 Participants
n=330 Participants
|
174 Participants
n=657 Participants
|
|
Prior Pregnancy
13-19 wk of gestation
|
13 Participants
n=327 Participants
|
10 Participants
n=330 Participants
|
23 Participants
n=657 Participants
|
|
Payment for obstetric care
Uninsured/self-pay
|
17 Participants
n=327 Participants
|
30 Participants
n=330 Participants
|
47 Participants
n=657 Participants
|
|
Payment for obstetric care
Private insurance
|
74 Participants
n=327 Participants
|
62 Participants
n=330 Participants
|
136 Participants
n=657 Participants
|
|
Payment for obstetric care
Government-assisted insurance
|
236 Participants
n=327 Participants
|
238 Participants
n=330 Participants
|
474 Participants
n=657 Participants
|
|
Married or living with partner
|
125 Participants
n=327 Participants
|
110 Participants
n=330 Participants
|
235 Participants
n=657 Participants
|
|
Alcohol use during pregnancy
|
33 Participants
n=327 Participants
|
20 Participants
n=330 Participants
|
53 Participants
n=657 Participants
|
|
Smoking during pregnancy
|
48 Participants
n=327 Participants
|
62 Participants
n=330 Participants
|
110 Participants
n=657 Participants
|
|
Illicit substance use during pregnancy
|
15 Participants
n=327 Participants
|
24 Participants
n=330 Participants
|
39 Participants
n=657 Participants
|
|
Gestational age at randomization
|
21.4 weeks
STANDARD_DEVIATION 1.2 • n=327 Participants
|
21.3 weeks
STANDARD_DEVIATION 1.3 • n=330 Participants
|
21.4 weeks
STANDARD_DEVIATION 1.3 • n=657 Participants
|
|
Cervical length at screening
|
23.9 mm
STANDARD_DEVIATION 5.6 • n=327 Participants
|
23.8 mm
STANDARD_DEVIATION 5.7 • n=330 Participants
|
23.8 mm
STANDARD_DEVIATION 5.7 • n=657 Participants
|
|
Cervical length at screening <15mm
|
25 Participants
n=327 Participants
|
31 Participants
n=330 Participants
|
56 Participants
n=657 Participants
|
|
Cervical funnel present
|
88 Participants
n=327 Participants
|
69 Participants
n=330 Participants
|
157 Participants
n=657 Participants
|
|
Cervical funnel length
|
14.8 mm
STANDARD_DEVIATION 8.0 • n=88 Participants • Includes only the patients that had a cervical funnel present.
|
16.7 mm
STANDARD_DEVIATION 8.7 • n=69 Participants • Includes only the patients that had a cervical funnel present.
|
15.6 mm
STANDARD_DEVIATION 8.4 • n=157 Participants • Includes only the patients that had a cervical funnel present.
|
|
Debris present
|
39 Participants
n=327 Participants
|
39 Participants
n=330 Participants
|
78 Participants
n=657 Participants
|
PRIMARY outcome
Timeframe: Delivery before 37 weeks gestationNumber of participants delivering before 37 weeks gestation by indication
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
|---|---|---|
|
Number of Participants Delivering Before 37 Weeks Gestation
Total Delivery <37 wk
|
82 Participants
|
80 Participants
|
|
Number of Participants Delivering Before 37 Weeks Gestation
Spontaneous
|
54 Participants
|
55 Participants
|
|
Number of Participants Delivering Before 37 Weeks Gestation
Medically indicated
|
27 Participants
|
25 Participants
|
|
Number of Participants Delivering Before 37 Weeks Gestation
Fetal loss/abortion <20 wk
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: DeliveryMean gestational age at delivery
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
|---|---|---|
|
Mean Gestational Age at Delivery
|
37.6 weeks
Standard Deviation 3.9
|
37.4 weeks
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: <37 weeksOutcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
|---|---|---|
|
Number of Participants With Preterm Premature Rupture of Membranes
|
25 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: DeliveryDelivery before 35 weeks gestation
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Delivered Before 35 Weeks Gestation
|
44 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: DeliveryDelivery before 32 weeks gestation
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Delivered Before 32 Weeks Gestation
|
28 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: DeliveryDelivery before 28 weeks gestation
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Delivered Before 28 Weeks Gestation
|
15 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Between randomization and 37 weeks gestationNumber of participants who visited the hospital due to preterm labor before 37 weeks gestation
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Visited the Hospital Due to Preterm Labor
|
145 Participants
|
151 Participants
|
SECONDARY outcome
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeksPopulation: Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.
Number of participants who underwent tocolytic therapy during pregnancy
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=321 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=325 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Underwent Tocolytic Therapy
|
35 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeksPopulation: Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.
Number of participants who underwent corticosteroid therapy in pregnancy
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=321 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=325 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Underwent Corticosteroid Therapy
|
55 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeksPopulation: Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.
Number of participants who had a cerclage placement
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=321 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=325 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Had a Cerclage Placement
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeksPopulation: Data was missing for 1 participant in the placebo group.
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=329 Participants
castor oil
|
|---|---|---|
|
Number of Participants Experiencing Gestational Hypertension or Preeclampsia
|
46 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeksOutcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
|---|---|---|
|
Number of Participants With Gestational Diabetes Mellitus
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeksPopulation: Data was missing for 1 participant in the Placebo group
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=329 Participants
castor oil
|
|---|---|---|
|
Number of Participants Experiencing Cholestasis
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeksPopulation: Data was missing for 2 participants in the placebo group.
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=328 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Experienced Placental Abruption
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeksPopulation: Data was missing for 2 participants in the placebo group.
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=328 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Experienced Chorioamnionitis
|
29 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: deliveryPopulation: Data was missing for 1 participant in the placebo group.
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=329 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Had Cesarean Delivery
|
67 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeksPopulation: Data was missing for 1 participant in the treatment group and 2 participants in the placebo group.
Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=326 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=328 Participants
castor oil
|
|---|---|---|
|
Number of Participants Who Reported Side Effects
Any
|
223 Participants
|
220 Participants
|
|
Number of Participants Who Reported Side Effects
Injection site
|
217 Participants
|
209 Participants
|
|
Number of Participants Who Reported Side Effects
Urticaria
|
10 Participants
|
2 Participants
|
|
Number of Participants Who Reported Side Effects
Nausea
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: within 72 hours of deliveryPopulation: With the exception of the composite outcome and death, the neonatal outcomes were only measured for live births.
comprised of fetal or infant death, respiratory distress syndrome, intraventricular hemorrhage (grades 3 and 4), periventricular leukomalacia, necrotizing enterocolitis (stage II and III), Bronchopulmonary dysplasia /chronic lung disease, retinopathy of prematurity (stage III or higher), early onset sepsis
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
|---|---|---|
|
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Composite Outcome Total
|
23 Participants
|
30 Participants
|
|
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Fetal Death
|
4 Participants
|
1 Participants
|
|
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Neonatal Death
|
6 Participants
|
8 Participants
|
|
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Respiratory Distress Syndrome
|
13 Participants
|
16 Participants
|
|
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Bronchopulmonary dysplasia
|
3 Participants
|
5 Participants
|
|
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Necrotizing enterocolitis, grade II or III
|
2 Participants
|
5 Participants
|
|
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Intraventricular Hemorrhage, Grade III or IV
|
2 Participants
|
1 Participants
|
|
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Periventricular Leukomalacia
|
4 Participants
|
1 Participants
|
|
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Early-onset Sepsis
|
3 Participants
|
11 Participants
|
|
Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Retinopathy of prematurity, grade II or IV
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: DeliveryBirth weight as measured in grams
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=327 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=330 Participants
castor oil
|
|---|---|---|
|
Mean Birth Weight
|
2855 Grams
Standard Deviation 747
|
2824 Grams
Standard Deviation 807
|
SECONDARY outcome
Timeframe: DeliveryPopulation: Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.
Birth weight by count of participants \< 2500 grams and \< 1500 grams
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=323 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=328 Participants
castor oil
|
|---|---|---|
|
Birth Weight by Count of Participants
Birth weight < 2500g
|
72 Participants
|
75 Participants
|
|
Birth Weight by Count of Participants
Birth weight < 1500g
|
23 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: DeliveryPopulation: Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.
Birth weight percentile and small for gestational age \<10th percentile based on number of weeks and gender.
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=323 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=328 Participants
castor oil
|
|---|---|---|
|
Number of Neonates Who Measured Small for Gestational Age
< 10th percentile
|
54 Participants
|
47 Participants
|
|
Number of Neonates Who Measured Small for Gestational Age
< 3rd percentile
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 5 minutes post deliveryPopulation: Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.
The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score.
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=323 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=328 Participants
castor oil
|
|---|---|---|
|
Number of Participants With Apgar Score of Less Than 7 at 5 Minutes
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: DeliveryPopulation: Data was missing for 1 participant in the treatment group and 2 participants in the placebo group.
Presence of a major congenital anomaly at birth
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=326 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=328 Participants
castor oil
|
|---|---|---|
|
Number of Neonates With a Major Congenital Anomaly
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Delivery through neonatal dischargePopulation: Data was missing for 7 participants in the treatment group and 8 participants in the placebo group.
Number of neonates diagnosed with the heart defect patent ductus arteriosus
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=320 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=322 Participants
castor oil
|
|---|---|---|
|
Number of Neonates With Patent Ductus Arteriosus
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Delivery through neonatal dischargePopulation: Data was missing for 7 participants in the treatment group and 8 participants in the placebo group.
Number of neonates experiencing seizures from delivery to hospital discharge
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=320 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=322 Participants
castor oil
|
|---|---|---|
|
Number of Neonates Experiencing Seizures
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Delivery through hospital dischargePopulation: Data was missing for 5 participants in the treatment group and 1 participant in the placebo group.
Admission to the neonatal intensive care unit
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=322 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=329 Participants
castor oil
|
|---|---|---|
|
Number of Neonates Admitted to NICU
|
63 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: NICU admission through NICU dischargePopulation: Data was missing for 5 participants in the treatment group and 1 participant in the placebo group.
Median length of stay in the neonatal intensive care unit in days
Outcome measures
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=322 Participants
17 alpha-hydroxyprogesterone caproate
17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=329 Participants
castor oil
|
|---|---|---|
|
Median Length of NICU Stay
|
17 days
Interval 6.0 to 43.0
|
15.5 days
Interval 6.0 to 57.5
|
Adverse Events
17 Alpha-hydroxyprogesterone Caproate
Serious events: 22 serious events
Other events: 326 other events
Deaths: 0 deaths
Placebo
Serious events: 13 serious events
Other events: 328 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=326 participants at risk；n=327 participants at risk
250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery
17 alpha-hydroxyprogesterone caproate: Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=328 participants at risk；n=330 participants at risk
Placebo oil given by weekly injection until 37 weeks gestation or delivery.
Placebo Oil: Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage or stillbirth
|
1.5%
5/327 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.30%
1/330 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Pregnancy, puerperium and perinatal conditions
Placental abruption
|
0.61%
2/327 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.61%
2/330 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy Complications
|
0.92%
3/327 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.91%
3/330 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Vascular disorders
Chest Pain
|
0.31%
1/327 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.00%
0/330 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Vascular disorders
Epistaxis
|
0.31%
1/327 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.00%
0/330 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Cardiac disorders
Maternal Pulmonary edema
|
0.31%
1/327 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.00%
0/330 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Blood and lymphatic system disorders
Maternal blood disorders
|
0.61%
2/327 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.00%
0/330 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Congenital, familial and genetic disorders
Congenital Anomalies
|
1.5%
5/327 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.91%
3/330 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
General disorders
Neonatal death
|
1.8%
6/327 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
2.4%
8/330 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Blood and lymphatic system disorders
Neonatal Hematochromatosis
|
0.31%
1/327 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.00%
0/330 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
Other adverse events
| Measure |
17 Alpha-hydroxyprogesterone Caproate
n=326 participants at risk；n=327 participants at risk
250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery
17 alpha-hydroxyprogesterone caproate: Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
|
Placebo
n=328 participants at risk；n=330 participants at risk
Placebo oil given by weekly injection until 37 weeks gestation or delivery.
Placebo Oil: Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative
|
|---|---|---|
|
General disorders
Headache
|
2.1%
7/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
2.4%
8/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
General disorders
Fatigue
|
1.5%
5/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.61%
2/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Gastrointestinal disorders
Nausea
|
2.1%
7/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
3.0%
10/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
6/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.91%
3/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Gastrointestinal disorders
Diarrhea
|
0.61%
2/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
1.8%
6/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Skin and subcutaneous tissue disorders
Reaction at injection site
|
66.6%
217/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
64.0%
210/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Skin and subcutaneous tissue disorders
Sore/burn at injection site
|
44.5%
145/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
46.6%
153/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Skin and subcutaneous tissue disorders
Itching at injection site
|
37.1%
121/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
33.2%
109/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Skin and subcutaneous tissue disorders
Swelling/lump at injection site
|
32.8%
107/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
28.4%
93/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Skin and subcutaneous tissue disorders
Bruising at injection site
|
8.0%
26/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
7.0%
23/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Skin and subcutaneous tissue disorders
Redness at injection site
|
2.5%
8/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
3.4%
11/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.1%
10/326 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
0.61%
2/328 • Adverse event data was collected during the study period of April 2007 through June 2010, from the time of the participants randomization through hospital discharge of the mother and baby (up to 60 days).
Other adverse events that are related to side effects are available for patients who had at least 1 study visit. 1 randomized participant in the treatment group and 2 randomized participants in the placebo group did not attend a study visit after randomization. Therefore the Ns for other side effects are different than those for the serious adverse events and the study sample (by 3 participants total).
|
Additional Information
William Grobman, MD
Northwestern University Medical School
Phone: 312-472-4661
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place