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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

December 16, 2008
December 17, 2008
August 30, 2011
December 2010
December 2012   (Final data collection date for primary outcome measure)
efficacy [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT00809939 on ClinicalTrials.gov Archive Site
comfort of use and consequently of that compliance [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pregnancy
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
800
Same as current
December 2012
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00809939
0129-08-MMC Ver:1
No
Not Provided
Not Provided
Meir Medical Center
Meir Medical Center
Not Provided
Principal Investigator: Tal Biron-Shental, MD Meir Medical Center, Israel, Affiliated to Tel Aviv University
Meir Medical Center
August 2011

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