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17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

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ClinicalTrials.gov Identifier: NCT00809939
Recruitment Status : Unknown
Verified August 2011 by Meir Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : December 17, 2008
Last Update Posted : August 30, 2011
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date  ICMJE December 16, 2008
First Posted Date  ICMJE December 17, 2008
Last Update Posted Date August 30, 2011
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
efficacy [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00809939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
comfort of use and consequently of that compliance [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
Official Title  ICMJE Not Provided
Brief Summary

Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries.

The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pregnancy
Intervention  ICMJE
  • Drug: 17 alfa hydroxyprogesterone caproate
    weekly injection of 250 mg until 34 weeks gestation
  • Drug: natural progesterone
    previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
  • Drug: 17 alfa hydroxyprogesterone caproate
    weekly injection, 250 mg until 34 weeks gestation
  • Drug: vaginal progesterone
    daily vaginal progesterone 200 mg until 34 weeks gestation.
Study Arms  ICMJE
  • Active Comparator: 1
    previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
    Intervention: Drug: 17 alfa hydroxyprogesterone caproate
  • Active Comparator: 2
    previous preterm delivery, treatment with daily vaginal natural progesterone
    Intervention: Drug: natural progesterone
  • Active Comparator: 3
    short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
    Intervention: Drug: 17 alfa hydroxyprogesterone caproate
  • Active Comparator: 4
    short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
    Intervention: Drug: vaginal progesterone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week.
  • The subject has a short cervical length defined as 25 mm before 24 weeks gestation.
  • A singleton gestation.

Exclusion Criteria:

  • Multifetal pregnancy.
  • The subject has or will have a cervical cerclage in place.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809939
Other Study ID Numbers  ICMJE 0129-08-MMC Ver:1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meir Medical Center
Study Sponsor  ICMJE Meir Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tal Biron-Shental, MD Meir Medical Center, Israel, Affiliated to Tel Aviv University
PRS Account Meir Medical Center
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP