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17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies (170HP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Obstetrix Medical Group
ClinicalTrials.gov Identifier:
NCT00163020
First received: September 9, 2005
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
Results First Received: June 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Preterm Birth
Interventions: Drug: 17-alpha-hydroxyprogesterone caproate injectable
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Potential women carrying a twin or triplet pregnancy meeting defined inclusion and exclusion criteria were recruited from participating outpatient medical clinics from November, 2004 to August 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the pre-assignment period, subjects were consented to participate, giving a compliance injection of Castor Oil and brought back 5 to 9 days later for re-evaluation. Exclusions were made based on the presence of a reaction to the injection, not meeting inclusion/exclusion criteria or the participates desire not to participate.

Reporting Groups
  Description
1 Test Group (170HP) Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
2 - Control (Castor Oil) Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.

Participant Flow:   Overall Study
    1 Test Group (170HP)     2 - Control (Castor Oil)  
STARTED     216 [1]   105 [2]
COMPLETED     216 [1]   103 [3]
NOT COMPLETED     0     2  
Lost to Follow-up                 0                 2  
[1] Twins = 160 Triplets = 56
[2] Twins = 80 Triplets = 25
[3] Twins = 78 Triplets = 25



  Baseline Characteristics
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Reporting Groups
  Description
1 Test Group (170HP) Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
2 - Control (Castor Oil) Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
Total Total of all reporting groups

Baseline Measures
    1 Test Group (170HP)     2 - Control (Castor Oil)     Total  
Number of Participants  
[units: participants]
 		  216     105     321  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     216     105     321  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		     
twins     34.0  ± 5.8     34.5  ± 6.6     34.3  ± 6.2  
triplets     33.4  ± 5.0     33.6  ± 5.4     33.5  ± 5.2  
Gender  
[units: participants]
 		     
Female     216     105     321  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     216     105     321  



  Outcome Measures
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1.  Primary:   Newborn Respiratory Distress Syndrome (RDS)   [ Time Frame: Measured from delivery until 30 days after baby was discharged from the hospital ]
  Show Outcome Measure 1

2.  Primary:   Use of Oxygen Therapy at 28 Days of Newborn Life   [ Time Frame: Measured at 28 days after birth. ]
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3.  Primary:   Newborn Sepsis   [ Time Frame: measured during the first week following birth ]
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4.  Primary:   Newborn Pneumonia   [ Time Frame: measure during the first 28 days after birth. ]
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5.  Primary:   Newborn Intraventricular Hemorrhage Grade 3 or 4   [ Time Frame: measured during the first 28 days after birth ]
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6.  Primary:   Newborn Periventricular Leukomalacia (PVL)   [ Time Frame: measured in the first 28 days after birth. ]
  Show Outcome Measure 6

7.  Primary:   Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery   [ Time Frame: measured in the first 28 days after birth ]
  Show Outcome Measure 7

8.  Primary:   Newborn Retinopathy of Prematurity (ROP)   [ Time Frame: measured during the first 28 day after birth ]
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9.  Primary:   Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver   [ Time Frame: measured during the first 28 days after delivery ]
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10.  Primary:   Perinatal Death   [ Time Frame: measured from randomization to 28 days after birth. ]
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11.  Secondary:   Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, BPD, PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death)   [ Time Frame: measured as any event noted in the first 28 day following birth. ]
  Show Outcome Measure 11

12.  Secondary:   Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks   [ Time Frame: Gestational age noted at time of birth ]
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13.  Secondary:   Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks   [ Time Frame: noted at delivery ]
  Show Outcome Measure 13

14.  Secondary:   Newborn Gestational Age (GA) at Delivery   [ Time Frame: determined at the time of birth ]
  Show Outcome Measure 14

15.  Secondary:   Newborn Birthweight   [ Time Frame: measure following delivery ]
  Show Outcome Measure 15

16.  Secondary:   Participant Drop-out Rates   [ Time Frame: any time from randomization to completion of final dose of study medication ]
  Show Outcome Measure 16

17.  Secondary:   Participant Side Effects Requiring Cessation of Therapy   [ Time Frame: anytime from initial injection to final injection at 34 weeks. ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Kimberly Maurel
Organization: Obstetrix Medical Group, Inc
phone: 714-593-9171
e-mail: kimberly_maurel@pediatrix.com


Publications:
American College of Obstetricians & Gynecologists. Special problems of multiple gestation. Educational Bulletin 253, 1998.


Responsible Party: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT00163020     History of Changes
Other Study ID Numbers: OBX0003, OBX 0012
Study First Received: September 9, 2005
Results First Received: June 5, 2012
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration