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RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix (SCAN)

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ClinicalTrials.gov Identifier: NCT00439374
Recruitment Status : Terminated (Halted by NICHD after recommendation by DSMC to stop for futility)
First Posted : February 23, 2007
Results First Posted : April 11, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
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, Care Provider);   Primary Purpose: Prevention
Conditions Preterm Delivery
Cervical Length
Interventions Drug: 17 alpha-hydroxyprogesterone caproate
Other: Placebo Oil
Enrollment 657
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description

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.

castor oil
Period Title: Overall Study
Started 327 330
Completed 327 330
Not Completed 0 0
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo Total
Hide Arm/Group Description

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.

castor oil Total of all reporting groups
Overall Number of Baseline Participants 327 330 657
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 327 participants 330 participants 657 participants
22.8  (5.3) 21.6  (4.4) 22.2  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 330 participants 657 participants
Female
327
 100.0%
330
 100.0%
657
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Non-Hispanic white Number Analyzed 327 participants 330 participants 657 participants
76
  23.2%
74
  22.4%
150
  22.8%
Non-hispanic black Number Analyzed 327 participants 330 participants 657 participants
179
  54.7%
161
  48.8%
340
  51.8%
Hispanic white Number Analyzed 327 participants 330 participants 657 participants
19
   5.8%
38
  11.5%
57
   8.7%
Hispanic black Number Analyzed 327 participants 330 participants 657 participants
2
   0.6%
0
   0.0%
2
   0.3%
Asian Number Analyzed 327 participants 330 participants 657 participants
4
   1.2%
3
   0.9%
7
   1.1%
Other Number Analyzed 327 participants 330 participants 657 participants
47
  14.4%
54
  16.4%
101
  15.4%
Prepregnancy body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg^m2
Number Analyzed 327 participants 330 participants 657 participants
26.1  (6.9) 25.4  (6.5) 25.7  (6.7)
Prior Pregnancy  
Measure Type: Count of Participants
Unit of measure:  Participants
<13 wk of gestation Number Analyzed 327 participants 330 participants 657 participants
92
  28.1%
82
  24.8%
174
  26.5%
13-19 wk of gestation Number Analyzed 327 participants 330 participants 657 participants
13
   4.0%
10
   3.0%
23
   3.5%
Payment for obstetric care  
Measure Type: Count of Participants
Unit of measure:  Participants
Uninsured/self-pay Number Analyzed 327 participants 330 participants 657 participants
17
   5.2%
30
   9.1%
47
   7.2%
Private insurance Number Analyzed 327 participants 330 participants 657 participants
74
  22.6%
62
  18.8%
136
  20.7%
Government-assisted insurance Number Analyzed 327 participants 330 participants 657 participants
236
  72.2%
238
  72.1%
474
  72.1%
Married or living with partner  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 330 participants 657 participants
125
  38.2%
110
  33.3%
235
  35.8%
Alcohol use during pregnancy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 330 participants 657 participants
33
  10.1%
20
   6.1%
53
   8.1%
Smoking during pregnancy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 330 participants 657 participants
48
  14.7%
62
  18.8%
110
  16.7%
Illicit substance use during pregnancy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 330 participants 657 participants
15
   4.6%
24
   7.3%
39
   5.9%
Gestational age at randomization  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 327 participants 330 participants 657 participants
21.4  (1.2) 21.3  (1.3) 21.4  (1.3)
Cervical length at screening  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 327 participants 330 participants 657 participants
23.9  (5.6) 23.8  (5.7) 23.8  (5.7)
Cervical length at screening <15mm  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 330 participants 657 participants
25
   7.6%
31
   9.4%
56
   8.5%
Cervical funnel present  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 330 participants 657 participants
88
  26.9%
69
  20.9%
157
  23.9%
Cervical funnel length   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 88 participants 69 participants 157 participants
14.8  (8.0) 16.7  (8.7) 15.6  (8.4)
[1]
Measure Analysis Population Description: Includes only the patients that had a cervical funnel present.
Debris present  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 330 participants 657 participants
39
  11.9%
39
  11.8%
78
  11.9%
1.Primary Outcome
Title Number of Participants Delivering Before 37 Weeks Gestation
Hide Description Number of participants delivering before 37 weeks gestation by indication
Time Frame Delivery before 37 weeks gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 330
Measure Type: Count of Participants
Unit of Measure: Participants
Total Delivery <37 wk
82
  25.1%
80
  24.2%
Spontaneous
54
  16.5%
55
  16.7%
Medically indicated
27
   8.3%
25
   7.6%
Fetal loss/abortion <20 wk
1
   0.3%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments All deliveries less than 37 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.79 to 1.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments Spontaneous deliveries
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.70 to 1.40
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments Medically-indicated deliveries
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.65 to 1.84
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Gestational Age at Delivery
Hide Description Mean gestational age at delivery
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 330
Mean (Standard Deviation)
Unit of Measure: weeks
37.6  (3.9) 37.4  (4.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Preterm Premature Rupture of Membranes
Hide Description [Not Specified]
Time Frame <37 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 330
Measure Type: Count of Participants
Unit of Measure: Participants
25
   7.6%
24
   7.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.61 to 1.80
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Who Delivered Before 35 Weeks Gestation
Hide Description Delivery before 35 weeks gestation
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 330
Measure Type: Count of Participants
Unit of Measure: Participants
44
  13.5%
53
  16.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.58 to 1.21
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Who Delivered Before 32 Weeks Gestation
Hide Description Delivery before 32 weeks gestation
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 330
Measure Type: Count of Participants
Unit of Measure: Participants
28
   8.6%
32
   9.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.54 to 1.43
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Who Delivered Before 28 Weeks Gestation
Hide Description Delivery before 28 weeks gestation
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 330
Measure Type: Count of Participants
Unit of Measure: Participants
15
   4.6%
22
   6.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.36 to 1.30
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants Who Visited the Hospital Due to Preterm Labor
Hide Description Number of participants who visited the hospital due to preterm labor before 37 weeks gestation
Time Frame Between randomization and 37 weeks gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 330
Measure Type: Count of Participants
Unit of Measure: Participants
145
  44.3%
151
  45.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.82 to 1.15
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants Who Underwent Tocolytic Therapy
Hide Description Number of participants who underwent tocolytic therapy during pregnancy
Time Frame Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 321 325
Measure Type: Count of Participants
Unit of Measure: Participants
35
  10.9%
42
  12.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.55 to 1.29
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants Who Underwent Corticosteroid Therapy
Hide Description Number of participants who underwent corticosteroid therapy in pregnancy
Time Frame Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 321 325
Measure Type: Count of Participants
Unit of Measure: Participants
55
  17.1%
51
  15.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.77 to 1.55
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants Who Had a Cerclage Placement
Hide Description Number of participants who had a cerclage placement
Time Frame Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 321 325
Measure Type: Count of Participants
Unit of Measure: Participants
6
   1.9%
4
   1.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
0.43 to 5.33
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants Experiencing Gestational Hypertension or Preeclampsia
Hide Description [Not Specified]
Time Frame Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 1 participant in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 329
Measure Type: Count of Participants
Unit of Measure: Participants
46
  14.1%
40
  12.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.78 to 1.72
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants With Gestational Diabetes Mellitus
Hide Description [Not Specified]
Time Frame Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 330
Measure Type: Count of Participants
Unit of Measure: Participants
15
   4.6%
13
   3.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.56 to 2.41
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants Experiencing Cholestasis
Hide Description [Not Specified]
Time Frame Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 1 participant in the Placebo group
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 329
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.3%
0
   0.0%
14.Secondary Outcome
Title Number of Participants Who Experienced Placental Abruption
Hide Description [Not Specified]
Time Frame Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 2 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 328
Measure Type: Count of Participants
Unit of Measure: Participants
11
   3.4%
15
   4.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.34 to 1.58
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Number of Participants Who Experienced Chorioamnionitis
Hide Description [Not Specified]
Time Frame Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 2 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 328
Measure Type: Count of Participants
Unit of Measure: Participants
29
   8.9%
20
   6.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
0.84 to 2.52
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Number of Participants Who Had Cesarean Delivery
Hide Description [Not Specified]
Time Frame delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 1 participant in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 329
Measure Type: Count of Participants
Unit of Measure: Participants
67
  20.5%
63
  19.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.79 to 1.46
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Number of Participants Who Reported Side Effects
Hide Description Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site
Time Frame Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 1 participant in the treatment group and 2 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 326 328
Measure Type: Count of Participants
Unit of Measure: Participants
Any
223
  68.4%
220
  67.1%
Injection site
217
  66.6%
209
  63.7%
Urticaria
10
   3.1%
2
   0.6%
Nausea
7
   2.1%
10
   3.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments Any side effect
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.92 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments Injection site
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.93 to 1.17
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments Urticaria
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 5.03
Confidence Interval (2-Sided) 95%
1.11 to 22.78
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments Nausea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.27 to 1.83
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components
Hide Description 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
Time Frame within 72 hours of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
With the exception of the composite outcome and death, the neonatal outcomes were only measured for live births.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 330
Measure Type: Count of Participants
Unit of Measure: Participants
Composite Outcome Total Number Analyzed 327 participants 330 participants
23
   7.0%
30
   9.1%
Fetal Death Number Analyzed 327 participants 330 participants
4
   1.2%
1
   0.3%
Neonatal Death Number Analyzed 327 participants 330 participants
6
   1.8%
8
   2.4%
Respiratory Distress Syndrome Number Analyzed 320 participants 323 participants
13
   4.1%
16
   5.0%
Bronchopulmonary dysplasia Number Analyzed 320 participants 322 participants
3
   0.9%
5
   1.6%
Necrotizing enterocolitis, grade II or III Number Analyzed 320 participants 322 participants
2
   0.6%
5
   1.6%
Intraventricular Hemorrhage, Grade III or IV Number Analyzed 320 participants 322 participants
2
   0.6%
1
   0.3%
Periventricular Leukomalacia Number Analyzed 327 participants 330 participants
4
   1.2%
1
   0.3%
Early-onset Sepsis Number Analyzed 320 participants 322 participants
3
   0.9%
11
   3.4%
Retinopathy of prematurity, grade II or IV Number Analyzed 320 participants 322 participants
1
   0.3%
3
   0.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments Analysis is for the total composite
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.46 to 1.30
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Mean Birth Weight
Hide Description Birth weight as measured in grams
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 327 330
Mean (Standard Deviation)
Unit of Measure: Grams
2855  (747) 2824  (807)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Secondary Outcome
Title Birth Weight by Count of Participants
Hide Description Birth weight by count of participants < 2500 grams and < 1500 grams
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 323 328
Measure Type: Count of Participants
Unit of Measure: Participants
Birth weight < 2500g
72
  22.3%
75
  22.9%
Birth weight < 1500g
23
   7.1%
29
   8.8%
21.Secondary Outcome
Title Number of Neonates Who Measured Small for Gestational Age
Hide Description Birth weight percentile and small for gestational age <10th percentile based on number of weeks and gender.
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 323 328
Measure Type: Count of Participants
Unit of Measure: Participants
< 10th percentile
54
  16.7%
47
  14.3%
< 3rd percentile
15
   4.6%
14
   4.3%
22.Secondary Outcome
Title Number of Participants With Apgar Score of Less Than 7 at 5 Minutes
Hide Description 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.
Time Frame 5 minutes post delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 323 328
Measure Type: Count of Participants
Unit of Measure: Participants
15
   4.6%
19
   5.8%
23.Secondary Outcome
Title Number of Neonates With a Major Congenital Anomaly
Hide Description Presence of a major congenital anomaly at birth
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 1 participant in the treatment group and 2 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 326 328
Measure Type: Count of Participants
Unit of Measure: Participants
6
   1.8%
2
   0.6%
24.Secondary Outcome
Title Number of Neonates With Patent Ductus Arteriosus
Hide Description Number of neonates diagnosed with the heart defect patent ductus arteriosus
Time Frame Delivery through neonatal discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 7 participants in the treatment group and 8 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.6%
8
   2.5%
25.Secondary Outcome
Title Number of Neonates Experiencing Seizures
Hide Description Number of neonates experiencing seizures from delivery to hospital discharge
Time Frame Delivery through neonatal discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 7 participants in the treatment group and 8 participants in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 320 322
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.3%
2
   0.6%
26.Secondary Outcome
Title Number of Neonates Admitted to NICU
Hide Description Admission to the neonatal intensive care unit
Time Frame Delivery through hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 5 participants in the treatment group and 1 participant in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 322 329
Measure Type: Count of Participants
Unit of Measure: Participants
63
  19.6%
69
  21.0%
27.Secondary Outcome
Title Median Length of NICU Stay
Hide Description Median length of stay in the neonatal intensive care unit in days
Time Frame NICU admission through NICU discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Data was missing for 5 participants in the treatment group and 1 participant in the placebo group.
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description:

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.

castor oil
Overall Number of Participants Analyzed 322 329
Median (Inter-Quartile Range)
Unit of Measure: days
17
(6 to 43)
15.5
(6 to 57.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17 Alpha-hydroxyprogesterone Caproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 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).
Adverse Event Reporting Description 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).
 
Arm/Group Title 17 Alpha-hydroxyprogesterone Caproate Placebo
Hide Arm/Group Description

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 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

All-Cause Mortality
17 Alpha-hydroxyprogesterone Caproate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
17 Alpha-hydroxyprogesterone Caproate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   22/327 (6.73%)   13/330 (3.94%) 
Blood and lymphatic system disorders     
Maternal blood disorders * [1]  2/327 (0.61%)  0/330 (0.00%) 
Neonatal Hematochromatosis *  1/327 (0.31%)  0/330 (0.00%) 
Cardiac disorders     
Maternal Pulmonary edema * [2]  1/327 (0.31%)  0/330 (0.00%) 
Congenital, familial and genetic disorders     
Congenital Anomalies * [3]  5/327 (1.53%)  3/330 (0.91%) 
General disorders     
Neonatal death *  6/327 (1.83%)  8/330 (2.42%) 
Pregnancy, puerperium and perinatal conditions     
Miscarriage or stillbirth  [4]  5/327 (1.53%)  1/330 (0.30%) 
Placental abruption *  2/327 (0.61%)  2/330 (0.61%) 
Pregnancy Complications * [5]  3/327 (0.92%)  3/330 (0.91%) 
Vascular disorders     
Chest Pain *  1/327 (0.31%)  0/330 (0.00%) 
Epistaxis * [6]  1/327 (0.31%)  0/330 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Pulmonary embolism, thrombocytopenia
[2]
due to anemia and cardiac insufficiency
[3]
ovarian cyst, esophageal atresia, flexion contracture, hypospadias, patent ductus arteriosis, polydactyly, torticollis, Trisomy 21
[4]
Miscarriage, antepartum stillbirth, intrapartum stillbirth
[5]
advanced cervical dilation, oligohydramnios, preterm rupture of the membranes
[6]
Nosebleed
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
17 Alpha-hydroxyprogesterone Caproate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   326/326 (100.00%)   328/328 (100.00%) 
Gastrointestinal disorders     
Nausea *  7/326 (2.15%)  10/328 (3.05%) 
Vomiting *  6/326 (1.84%)  3/328 (0.91%) 
Diarrhea *  2/326 (0.61%)  6/328 (1.83%) 
General disorders     
Headache *  7/326 (2.15%)  8/328 (2.44%) 
Fatigue *  5/326 (1.53%)  2/328 (0.61%) 
Skin and subcutaneous tissue disorders     
Reaction at injection site *  217/326 (66.56%)  210/328 (64.02%) 
Sore/burn at injection site *  145/326 (44.48%)  153/328 (46.65%) 
Itching at injection site *  121/326 (37.12%)  109/328 (33.23%) 
Swelling/lump at injection site *  107/326 (32.82%)  93/328 (28.35%) 
Bruising at injection site *  26/326 (7.98%)  23/328 (7.01%) 
Redness at injection site *  8/326 (2.45%)  11/328 (3.35%) 
Urticaria *  10/326 (3.07%)  2/328 (0.61%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: William Grobman, MD
Organization: Northwestern University Medical School
Phone: 312-472-4661
EMail: w-grobman@northwestern.edu
Layout table for additonal information
Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT00439374     History of Changes
Other Study ID Numbers: HD36801 SCAN
U10HD021410 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD027917 ( U.S. NIH Grant/Contract )
U10HD053097 ( U.S. NIH Grant/Contract )
U10HD027915 ( U.S. NIH Grant/Contract )
U10HD034116 ( U.S. NIH Grant/Contract )
U10HD034208 ( U.S. NIH Grant/Contract )
U10HD034136 ( 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 )
U10HD053118 ( U.S. NIH Grant/Contract )
First Submitted: February 21, 2007
First Posted: February 23, 2007
Results First Submitted: February 28, 2019
Results First Posted: April 11, 2019
Last Update Posted: July 15, 2019