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Trial record 73 of 272 for:    Betamethasone

Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial (ALPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01222247
Recruitment Status : Active, not recruiting
First Posted : October 18, 2010
Results First Posted : January 30, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Pregnancy
Respiratory Distress Syndrome
Pregnancy Outcomes
Preterm Birth
Interventions Drug: Betamethasone
Drug: Placebo
Enrollment 2831
Recruitment Details Participants were recruited from October 2010 to February 2015 at 17 university-based clinical centers. Women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation and a high probability of delivery in the late preterm period were eligible to be enrolled.
Pre-assignment Details  
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Period Title: Overall Study
Started 1429 1402
Received 2 Doses 860 826
Received 1 Dose 568 571
Did Not Receive Assigned Medication 1 5
Completed 1427 1400
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
Arm/Group Title Betamethasone Placebo Total
Hide Arm/Group Description

A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

Betamethasone: The active study drug, betamethasone. 3 mg per ml betamethasone sodium phosphate 3 mg per milliliter betamethasone acetate The first dose of study drug medication will be administered at randomization as 2 ml injection; the next dose of 2 ml will be administered 24 hours later.

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Total of all reporting groups
Overall Number of Baseline Participants 1429 1402 2831
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Mean maternal age Number Analyzed 1429 participants 1402 participants 2831 participants
28.6  (6.3) 27.8  (6.1) 28.2  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1429 participants 1402 participants 2831 participants
Female
1429
 100.0%
1402
 100.0%
2831
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1429 participants 1402 participants 2831 participants
Black
376
  26.3%
381
  27.2%
757
  26.7%
White
828
  57.9%
800
  57.1%
1628
  57.5%
Hispanic
168
  11.8%
182
  13.0%
350
  12.4%
Other, unknown, more than one race
57
   4.0%
39
   2.8%
96
   3.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1429 participants 1402 participants 2831 participants
1429 1402 2831
Indication for trial entry  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1429 participants 1402 participants 2831 participants
Preterm labor with intact membranes
400
  28.0%
392
  28.0%
792
  28.0%
Ruptured membranes
316
  22.1%
304
  21.7%
620
  21.9%
Exp delivery for gestational HTN or preeclampsia
370
  25.9%
385
  27.5%
755
  26.7%
Expected delivery for fetal growth restriction
46
   3.2%
48
   3.4%
94
   3.3%
Expected delivery for oligohydramnios
50
   3.5%
42
   3.0%
92
   3.2%
Expected delivery for other indication
247
  17.3%
231
  16.5%
478
  16.9%
Gestational age at trial entry  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1429 participants 1402 participants 2831 participants
≤34 weeks 6 days
369
  25.8%
399
  28.5%
768
  27.1%
35 weeks 0 days to 35 weeks 6 days
571
  40.0%
532
  37.9%
1103
  39.0%
≥36 weeks 0 days
489
  34.2%
471
  33.6%
960
  33.9%
Smoking during pregnancy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1429 participants 1402 participants 2831 participants
204
  14.3%
186
  13.3%
390
  13.8%
Nulliparous  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1429 participants 1402 participants 2831 participants
457
  32.0%
448
  32.0%
905
  32.0%
Preeclampsia or gestational hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1429 participants 1402 participants 2831 participants
433
  30.3%
440
  31.4%
873
  30.8%
Gestational diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1429 participants 1402 participants 2831 participants
153
  10.7%
153
  10.9%
306
  10.8%
Major congenital anomaly in infant   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1429 participants 1402 participants 2831 participants
11
   0.8%
21
   1.5%
32
   1.1%
[1]
Measure Description: Although the presence of a major congenital anomaly was an exclusion criterion, these disorders were not discovered until birth. Therefore we report this as a baseline measure on the publication and not an outcome. To be consistent with the publication, we report this as a baseline measure here.
1.Primary Outcome
Title Neonatal Composite Outcome
Hide Description Need for respiratory support: Continuous positive airway pressure (CPAP) or humidified high-flow nasal cannula (HHFNC) for greater than or equal to 2 hours or more in the first 72 hours, or fraction of inspired oxygen (FiO2) greater than or equal to 0.30 for 4 hours or more in the first 72 hours, or mechanical ventilation in the first 72 hours, or Extracorporeal membrane oxygenation (ECMO) Stillbirth, or neonatal death less than 72 hours of age
Time Frame 72 hours of life
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
Primary Outcome Composite
165
  11.6%
202
  14.4%
CPAP or high-flow cannula ≥2 continuous hrs
145
  10.2%
184
  13.1%
Fraction of inspired O2 of ≥0.30 for ≥4 cont hrs
48
   3.4%
61
   4.4%
Mechanical ventilation
34
   2.4%
43
   3.1%
Extracorporeal membrane oxygenation (ECMO)
0
   0.0%
0
   0.0%
Stillbirth or neonatal death ≤72 hr after birth
0
   0.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments Analysis for Primary Outcome composite
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.66 to 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments Analysis for CPAP or high-flow nasal cannula
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.63 to 0.95
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments Analysis for Fraction of inspired oxygen
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.53 to 1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments Analysis for mechanical ventilation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.50 to 1.21
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Neonates With Severe Respiratory Complication,
Hide Description A severe respiratory complication was defined as any of the following occurrences within 72 hours after birth: CPAP or high-flow nasal cannula for at least 12 hours, supplemental oxygen with a fraction of inspired oxygen of 0.30 or more for at least 24 hours, mechanical ventilation, stillbirth or neonatal death, or the need for ECMO. Except for the duration of CPAP or high-flow nasal cannula and the duration of a fraction of inspired oxygen of 0.30 or more, the criteria for a severe respiratory complication overlap with those of the primary outcome.
Time Frame 72 hours of life
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
Severe Respiratory Complication Composite
114
   8.0%
169
  12.1%
CPAP or high-flow cannula ≥12 continuous hrs
93
   6.5%
147
  10.5%
Fraction of inspired 02 of ≥0.30 for ≥24 cont hrs
20
   1.4%
34
   2.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.53 to 0.84
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Neonates Needing Immediate Resuscitation After Birth
Hide Description Need for resuscitation after birth: any intervention in the first 30 minutes other than blow-by oxygen
Time Frame Within the first 30 minutes of birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1422 1390
Measure Type: Count of Participants
Unit of Measure: Participants
206
  14.5%
260
  18.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.66 to 0.92
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Neonates With Respiratory Distress Syndrome
Hide Description Respiratory distress defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis) with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
79
   5.5%
89
   6.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.65 to 1.17
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Neonates With Transient Tachypnea of the Newborn
Hide Description TTN is defined as signs of respiratory distress, specifically tachypnea, that are resolved by 72 hours of age. TTN may be diagnosed in the absence of a chest X-ray or with a chest X-ray that is normal or shows signs of increased perihilar interstitial markings
Time Frame by 72 hours after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
95
   6.7%
138
   9.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.53 to 0.87
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Infants With Neonatal Apnea
Hide Description Neonatal apnea with respiratory pauses of more than 20 seconds duration resulting in bradycardia or oxygen desaturation below baseline.
Time Frame 72 hours of life
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
33
   2.3%
37
   2.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.55 to 1.39
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Infants withChronic Lung Disease / Bronchopulmonary Dysplasia (BPD) Requiring Supplemental Oxygen
Hide Description Infants requiring supplemental oxygen of more than 0.21 for the first 28 days of life
Time Frame 28 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.1%
9
   0.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
0.02 to 0.92
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Neonates With Pneumonia
Hide Description Neonatal pneumonia
Time Frame by 72 hours of life
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
6
   0.4%
13
   0.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.17 to 1.19
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Neonates Needing Surfactant Administration
Hide Description Administration of surfactant for neonatal respiratory treatment
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
26
   1.8%
43
   3.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.37 to 0.96
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Neonatal Outcome Composite
Hide Description Transient tachypnea of the newborn (TTN), respiratory distress syndrome (RDS), and apnea
Time Frame 72 hours of life
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
198
  13.9%
249
  17.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.66 to 0.93
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Neonates With Pulmonary Air Leak
Hide Description Neonatal pulmonary air leak syndrome
Time Frame 72 hours post delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.4%
6
   0.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.25 to 2.68
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Neonatal Death After 72 Hours of Delivery
Hide Description Neonatal death after 72 hours of life but before hospital discharge.
Time Frame 72 hours after delivery through hospital discharge up to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.1%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
13.Secondary Outcome
Title Birth Weight
Hide Description Weight in grams at delivery
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Mean (Standard Deviation)
Unit of Measure: grams
2637  (480) 2654  (484)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Birth Weight Less Than 10th Percentile
Hide Description Neonates whose birth weight is less than the 10th percentile at delivery
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
255
  17.9%
220
  15.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.96 to 1.34
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Gestational Age at Delivery
Hide Description Number of neonates delivered at ≤ 34 weeks 6 days, between 35 weeks 0 days and 35 weeks 6 days, between 36 weeks 0 days and 36 weeks 6 days, between 37 weeks 0 days and 38 weeks 6 days, or on or after 39 weeks 0 days
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
≤34 weeks 6 days
193
  13.5%
213
  15.2%
35 weeks 0 days to 35 weeks 6 days
394
  27.6%
386
  27.6%
36 weeks 0 days to 36 weeks 6 days
609
  42.7%
568
  40.6%
37 weeks 0 days to 38 weeks 6 days
202
  14.2%
185
  13.2%
≥39 weeks 0 days
29
   2.0%
48
   3.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
16.Secondary Outcome
Title Number of Neonates With Necrotizing Enterocolitic (NEC)
Hide Description Defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation.
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   0.1%
17.Secondary Outcome
Title Number of Infants With Neonatal Sepsis
Hide Description Clinical suspicion of systemic infection with a positive blood, cerebral spinal fluid, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evience of cardiovascular collapse or an X-ray confirming infection.
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
9
   0.6%
11
   0.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.33 to 1.93
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Number of Neonates With Intraventricular Hemorrhage
Hide Description Grade 3 or 4 Intraventricular Hemorrhage
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.1%
0
   0.0%
19.Secondary Outcome
Title Neonatal Morbidity Composite
Hide Description A composite endpoint of morbidities known to be affected by steroid administration will also be evaluated. Specifically, this composite will include RDS, intraventricular hemorrhage (IVH), and NEC
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
81
   5.7%
90
   6.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.66 to 1.18
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Number of Neonates With Hypoglycemia
Hide Description Glucose < 40 mg per deciliter (2.2 mmol per liter) at any time
Time Frame Delivery through hospital discharge up to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
343
  24.0%
210
  15.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
1.37 to 1.87
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Time Until First Neonatal Feeding
Hide Description Median length of time from delivery until the first neonatal feeding
Time Frame Delivery to 36 hours post delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Median (Inter-Quartile Range)
Unit of Measure: hours
5.5
(1.4 to 24.7)
9.9
(1.7 to 29.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
22.Secondary Outcome
Title Neonatal Feeding Difficulty
Hide Description Inability of the neonate to take all feeds (po), i.e. requiring gavage feeds or IV supplementation.
Time Frame Delivery to 36 hours post delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
211
  14.8%
223
  15.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.78 to 1.10
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Neonatal Hyperbilirubinemia
Hide Description Peak total bilirubin of at least 15 mg% or the use of phototherapy.
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
167
  11.7%
140
  10.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.95 to 1.40
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Number of Neonates With Hypothermia
Hide Description Rectal temperature < 36 C at any time
Time Frame Delivery through discharge up to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
132
   9.3%
112
   8.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.91 to 1.47
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Length of NICU or Nursery Stay
Hide Description Includes need for NICU or intermediate care admission and length of stay if admitted. For analysis purposes, death before discharge is assigned maximum rank
Time Frame Delivery through hospital discharge up to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
NICU stay of any duration
596
  41.8%
629
  44.9%
NICU stay of ≥3 days
470
  32.9%
518
  37.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments Analysis for NICU stay of any duration
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.85 to 1.01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments Analysis for duration greater than or equal to 3 days
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.80 to 0.98
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Median Length of Hospital Stay
Hide Description Median length of maternal hospital stay following delivery
Time Frame Duration of hospital stay following delivery up to 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Median (Inter-Quartile Range)
Unit of Measure: days
7
(4 to 12)
8
(4 to 13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
27.Secondary Outcome
Title Maternal Outcomes (Participant-based)
Hide Description Chorioamnionitis: clinical diagnosis and a body temperature of at least 100.4 degrees F., Endometritis: persistent postpartum temperature greater than 100.4 degrees F with uterine tenderness, cesarean delivery
Time Frame Labor and delivery through 72 hours post partum
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Measure Type: Count of Participants
Unit of Measure: Participants
Chorioamnionitis
20
   1.4%
32
   2.3%
Postpartum Endometritis
16
   1.1%
16
   1.1%
Cesarean Delivery
454
  31.8%
431
  30.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments Statistical analysis for chorioamnionitis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.35 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments Analysis for Postpartum Endometritis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.49 to 1.95
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments Statistical analysis for cesarean delivery
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.93 to 1.15
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Hours From Randomization to Delivery
Hide Description Median interval of hours from randomization to delivery
Time Frame Randomization through delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Median (Inter-Quartile Range)
Unit of Measure: Hours
33.0
(15.2 to 111.6)
30.6
(14.6 to 111.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments Analysis for interval from randomization to delivery
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
29.Secondary Outcome
Title Median Length of Maternal Hospital Stay
Hide Description Median length of maternal hospital stay in days
Time Frame Delivery through hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description:
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

Overall Number of Participants Analyzed 1427 1400
Median (Inter-Quartile Range)
Unit of Measure: days
3
(3 to 5)
3
(3 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Betamethasone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Adverse events were collected from the time of randomization into the study through 72 hours after delivery.
Adverse Event Reporting Description Adverse events were documented by research nurse coordinators and principal investigators on standardized study protocol forms and reported to the study sponsor. Non-serious adverse events are reported for patients who received 1 or 2 doses of drug or placebo. Not all participants who were randomized received a study injection.
 
Arm/Group Title Betamethasone Placebo
Hide Arm/Group Description A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart

A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.

All-Cause Mortality
Betamethasone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/1429 (0.14%)      0/1402 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Betamethasone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/1429 (0.91%)      12/1402 (0.86%)    
Blood and lymphatic system disorders     
Neonatal Thrombocytopenia *  1/1429 (0.07%)  0/1402 (0.00%) 
Cardiac disorders     
Aortic dissection type 1 *  0/1429 (0.00%)  1/1402 (0.07%) 
Cardiomyopathy *  0/1429 (0.00%)  2/1402 (0.14%) 
Gastrointestinal disorders     
Obstructed bowel * [1]  1/1429 (0.07%)  0/1402 (0.00%) 
General disorders     
Neonatal death * [2]  2/1429 (0.14%)  0/1402 (0.00%) 
Musculoskeletal and connective tissue disorders     
Lumbar plexus stretch injury * [3]  0/1429 (0.00%)  1/1402 (0.07%) 
Pregnancy, puerperium and perinatal conditions     
Postpartum Hemorrhage * [4]  7/1429 (0.49%)  5/1402 (0.36%) 
Seizure * [5]  1/1429 (0.07%)  1/1402 (0.07%) 
Uterine rupture * [6]  0/1429 (0.00%)  1/1402 (0.07%) 
Delayed pre-eclampsia * [6]  1/1429 (0.07%)  0/1402 (0.00%) 
Vascular disorders     
Hypotension * [7]  0/1429 (0.00%)  1/1402 (0.07%) 
*
Indicates events were collected by non-systematic assessment
[1]
Maternal obstructed bowel
[2]
Two infants died after 72 hours of life but before hospital discharge.
[3]
Maternal stretch injury
[4]
Postpartum Hemorrhage
[5]
Postpartum pregnancy complication
[6]
Pregnancy complication
[7]
Low blood pressure
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Betamethasone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   223/1428 (15.62%)      352/1397 (25.20%)    
Skin and subcutaneous tissue disorders     
Skin reaction at injecton site * [1]  223/1428 (15.62%)  223 352/1397 (25.20%)  352
*
Indicates events were collected by non-systematic assessment
[1]
Pain, bruising, swelling or other local reaction at the injection site with first and/or second dose
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth Thom, Ph.D.
Organization: The George Washington University Biostatistics Center
Phone: 301-881-9260
EMail: e_thom@bsc.gwu.edu
Other Publications:
Hamilton BE, Ventura SJ, Martin JA, and Sutton PD. Preliminary births for 2004. Health E-stats. Hyattsville, MD: National Center for Health Statistics. Released October 28, 2005.
Layout table for additonal information
Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT01222247     History of Changes
Other Study ID Numbers: HL98354-HD36801-ALPS
U10HD021410 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD027917 ( U.S. NIH Grant/Contract )
U10HD053118 ( U.S. NIH Grant/Contract )
U10HD027915 ( U.S. NIH Grant/Contract )
U10HD034116 ( U.S. NIH Grant/Contract )
U10HD034208 ( U.S. NIH Grant/Contract )
U10HD053097 ( U.S. NIH Grant/Contract )
U10HD040500 ( U.S. NIH Grant/Contract )
U10HD040485 ( U.S. NIH Grant/Contract )
U10HD040544 ( U.S. NIH Grant/Contract )
U10HD040545 ( U.S. NIH Grant/Contract )
U10HD040560 ( U.S. NIH Grant/Contract )
U10HD040512 ( U.S. NIH Grant/Contract )
U10HD036801 ( U.S. NIH Grant/Contract )
U01HL098354 ( U.S. NIH Grant/Contract )
U01HL098554 ( U.S. NIH Grant/Contract )
U10HD068268 ( U.S. NIH Grant/Contract )
U10HD068258 ( U.S. NIH Grant/Contract )
U10HD068282 ( U.S. NIH Grant/Contract )
First Submitted: October 14, 2010
First Posted: October 18, 2010
Results First Submitted: December 18, 2018
Results First Posted: January 30, 2019
Last Update Posted: July 12, 2019