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Trial record 17 of 48 for:    necrotizing enterocolitis | NIH

PREGNANT Short Cervix Trial

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ClinicalTrials.gov Identifier: NCT00615550
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : March 13, 2012
Last Update Posted : March 13, 2012
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Juniper Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Preterm Delivery
Short Cervix
Short Uterine Cervical Length
Interventions Drug: progesterone
Drug: placebo
Enrollment 465

Recruitment Details March 2008 to June 2010
Pre-assignment Details  
Arm/Group Title Placebo Prochieve
Hide Arm/Group Description placebo vaginal gel Progesterone 8% Vaginal Gel
Period Title: Overall Study
Started 229 236
Completed 223 235
Not Completed 6 1
Reason Not Completed
Lost to Follow-up             6             1
Arm/Group Title Placebo Prochieve Total
Hide Arm/Group Description placebo vaginal gel Progesterone 8% Vaginal Gel Total of all reporting groups
Overall Number of Baseline Participants 223 235 458
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 235 participants 458 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
223
 100.0%
235
 100.0%
458
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 223 participants 235 participants 458 participants
26.2  (5.1) 26.5  (5.8) 26.4  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 235 participants 458 participants
Female
223
 100.0%
235
 100.0%
458
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 223 participants 235 participants 458 participants
Belarus 7 5 12
United States 100 107 207
Czech Republic 1 3 4
Ukraine 26 28 54
South Africa 11 10 21
Russian Federation 0 1 1
Israel 0 3 3
Chile 2 0 2
Italy 3 5 8
India 73 73 146
1.Primary Outcome
Title Number of Participants With Birth <=32 6/7 Weeks Gestation.
Hide Description [Not Specified]
Time Frame 9 to 13 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Placebo Prochieve
Hide Arm/Group Description:
placebo vaginal gel
Progesterone 8% Vaginal Gel
Overall Number of Participants Analyzed 223 235
Measure Type: Number
Unit of Measure: participants
36 21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Prochieve
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.33 to 0.92
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)
Hide Description

Each infant is scored based on the 7 morbidity and mortality events above:

0= no morbidity event

  1. 1 morbidity event
  2. 2 morbidity events
  3. 3 or more morbidity events
  4. mortality
Time Frame Delivery Hospitalization (1-212 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Prochieve
Hide Arm/Group Description:
placebo vaginal gel
Progesterone 8% Vaginal Gel
Overall Number of Participants Analyzed 223 235
Measure Type: Number
Unit of Measure: participants
Composite score 0 192 217
Composite score 1 11 5
Composite score 2 8 2
Composite score 3 0 3
Composite score 4 11 8
Infants with RDS 17 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Prochieve
Comments Statistical analysis presented for composite score data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Prochieve
Comments Statistical analysis presented for RDS data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.17 to 0.92
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.
Hide Description Number of participants at <=27 6/7 , <=34 6/7, and <36 6/7.
Time Frame Gestational Age at Delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Placebo Prochieve
Hide Arm/Group Description:
placebo vaginal gel
Progesterone 8% Vaginal Gel
Overall Number of Participants Analyzed 223 235
Measure Type: Number
Unit of Measure: participants
Number of deliveries <= 27 6/7 weeks 23 12
Number of deliveries <= 34 6/7 weeks 52 34
Number of deliveries <= 36 weeks 76 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Prochieve
Comments Statistical analysis presented for births <=27 6/7 weeks data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.25 to 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Prochieve
Comments Statistical analysis presented for <= 34 6/7 weeks data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.42 to 0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Prochieve
Comments Statistical analysis presented for <36 weeks data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.376
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.68 to 1.16
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Neonates Who Died.
Hide Description [Not Specified]
Time Frame Delivery to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All infants with a known delivery date and status.
Arm/Group Title Placebo Prochieve
Hide Arm/Group Description:
placebo vaginal gel
Progesterone 8% Vaginal Gel
Overall Number of Participants Analyzed 223 235
Measure Type: Number
Unit of Measure: participants
5 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Prochieve
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.431
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.14 to 2.35
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams
Hide Description Assessment of birth weight < 1500 grams or < 2500 grams
Time Frame date of delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available birth weight.
Arm/Group Title Placebo Prochieve
Hide Arm/Group Description:
placebo vaginal gel
Progesterone 8% Vaginal Gel
Overall Number of Participants Analyzed 220 234
Measure Type: Number
Unit of Measure: participants
Birth weight < 1500 grams 30 15
Birth weight < 2500 grams 68 60
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Prochieve
Comments Statistical analysis for birth weight < 1500 grams data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.26 to 0.85
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Prochieve
Comments Statistical analysis for birth weight < 2500 grams data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.213
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.62 to 1.11
Estimation Comments [Not Specified]
Time Frame Randomization to delivery (1 day to 168 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Prochieve
Hide Arm/Group Description placebo vaginal gel Progesterone 8% Vaginal Gel
All-Cause Mortality
Placebo Prochieve
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Prochieve
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   98/224 (43.75%)      97/235 (41.28%)    
Blood and lymphatic system disorders     
anemia * 1  1/224 (0.45%)  1 1/235 (0.43%)  1
Cardiac disorders     
atrial fibrillation * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
Gastrointestinal disorders     
abdominal pain lower * 1  2/224 (0.89%)  2 2/235 (0.85%)  2
abdominal pain * 1  1/224 (0.45%)  1 2/235 (0.85%)  2
nausea * 1  1/224 (0.45%)  1 1/235 (0.43%)  1
diarrhoea * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
gastritis * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
vomiting * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
General disorders     
pyrexia * 1  2/224 (0.89%)  2 0/235 (0.00%)  0
Hepatobiliary disorders     
cholecysitis acute * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
gallbladder disorder * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
Immune system disorders     
hypersensitivity * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
Infections and infestations     
upper respiratory tract infection * 1  2/224 (0.89%)  2 2/235 (0.85%)  2
cytomegalovirus infection * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
pneumonia * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
ureaplasma infection * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
urinary tract infection * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
Injury, poisoning and procedural complications     
fall * 1  1/224 (0.45%)  1 2/235 (0.85%)  2
abdominal injury * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
Investigations     
feotal monitoring * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
Metabolism and nutrition disorders     
gestational diabetes * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
premature baby * 1  46/224 (20.54%)  46 44/235 (18.72%)  44
premature labor * 1  33/224 (14.73%)  33 17/235 (7.23%)  17
premature rupture of the membranes * 1  9/224 (4.02%)  9 12/235 (5.11%)  12
uterine contractions abnormal * 1  7/224 (3.13%)  7 5/235 (2.13%)  5
foetal distress abnormal * 1  3/224 (1.34%)  3 6/235 (2.55%)  6
cervical incompetence * 1  3/224 (1.34%)  3 4/235 (1.70%)  4
pre-eclampsia * 1  4/224 (1.79%)  4 2/235 (0.85%)  2
stillbirth * 1  3/224 (1.34%)  3 3/235 (1.28%)  3
chorioamnionitis * 1  3/224 (1.34%)  3 2/235 (0.85%)  2
foetal growth retardation * 1  4/224 (1.79%)  4 1/235 (0.43%)  1
pregnancy induced hypertension * 1  1/224 (0.45%)  1 4/235 (1.70%)  4
premature separation of placenta * 1  4/224 (1.79%)  4 1/235 (0.43%)  1
foetal heart rate deceleration * 1  2/224 (0.89%)  2 2/235 (0.85%)  2
intra-uterine death * 1  2/224 (0.89%)  2 2/235 (0.85%)  2
funisitis * 1  2/224 (0.89%)  2 1/235 (0.43%)  1
oligohydramnios * 1  1/224 (0.45%)  1 2/235 (0.85%)  2
HELLP syndrome * 1  1/224 (0.45%)  1 1/235 (0.43%)  1
postpartum haemorrhage * 1  2/224 (0.89%)  2 0/235 (0.00%)  0
bradycardia foetal * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
breech presentation * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
cholestasis of pregnancy * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
eclampsia * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
foetal movements decreased * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
obstructed labour * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
placenta accreta * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
tachycardia foetal * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
umbilical cord prolapse * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
vomiting in pregnancy * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
Renal and urinary disorders     
hydronephrosis * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
Reproductive system and breast disorders     
cervix disorder * 1  12/224 (5.36%)  12 21/235 (8.94%)  21
uterine pain * 1  1/224 (0.45%)  1 0/235 (0.00%)  0
vaginal discharge * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
Social circumstances     
physical assault * 1  0/224 (0.00%)  0 1/235 (0.43%)  1
Surgical and medical procedures     
cervix cerclage procedure * 1  5/224 (2.23%)  5 9/235 (3.83%)  9
maternal therapy to enhance foetal lung maturity * 1  1/224 (0.45%)  1 1/235 (0.43%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Placebo Prochieve
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/223 (10.76%)      30/235 (12.77%)    
Blood and lymphatic system disorders     
anaemia * 1  14/223 (6.28%)  14 15/235 (6.38%)  15
Gastrointestinal disorders     
abdominal pain * 1  11/223 (4.93%)  11 13/235 (5.53%)  13
Dyspepsia * 1  12/223 (5.38%)  12 15/235 (6.38%)  15
Nausea * 1  23/223 (10.31%)  23 23/235 (9.79%)  23
Infections and infestations     
Vaginitis bacterial * 1  6/223 (2.69%)  6 12/235 (5.11%)  12
Vulvovaginal mycotic infection * 1  11/223 (4.93%)  11 17/235 (7.23%)  17
urinary tract infection * 1  9/223 (4.04%)  9 11/235 (4.68%)  11
Metabolism and nutrition disorders     
gestational diabetes * 1  9/223 (4.04%)  9 14/235 (5.96%)  14
Musculoskeletal and connective tissue disorders     
back pain * 1  11/223 (4.93%)  11 12/235 (5.11%)  12
Nervous system disorders     
Headache * 1  18/223 (8.07%)  18 16/235 (6.81%)  16
Pregnancy, puerperium and perinatal conditions     
Bleeding peripartum * 1  14/223 (6.28%)  14 9/235 (3.83%)  9
Vomiting in pregnancy * 1  12/223 (5.38%)  12 10/235 (4.26%)  10
chorioamnionitis * 1  12/223 (5.38%)  12 12/235 (5.11%)  12
premature rupture of membranes * 1  10/223 (4.48%)  10 13/235 (5.53%)  13
foetal growth retardation * 1  11/223 (4.93%)  11 5/235 (2.13%)  5
Reproductive system and breast disorders     
Vaginal infection * 1  11/223 (4.93%)  11 15/235 (6.38%)  15
cervix disorder * 1  17/223 (7.62%)  17 23/235 (9.79%)  23
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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
Name/Title: George W Creasy MD
Organization: Columbia Laboratories
Phone: 973-486-8797
Responsible Party: Juniper Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00615550     History of Changes
Other Study ID Numbers: COL-1620-302
09-CH-N014
First Submitted: January 18, 2008
First Posted: February 14, 2008
Results First Submitted: February 24, 2012
Results First Posted: March 13, 2012
Last Update Posted: March 13, 2012