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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

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.


Condition or disease Intervention/treatment Phase
Pregnancy Drug: 17 alfa hydroxyprogesterone caproate Drug: natural progesterone Drug: vaginal progesterone Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : December 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
Drug: 17 alfa hydroxyprogesterone caproate
weekly injection of 250 mg until 34 weeks gestation

Active Comparator: 2
previous preterm delivery, treatment with daily vaginal natural progesterone
Drug: natural progesterone
previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.

Active Comparator: 3
short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
Drug: 17 alfa hydroxyprogesterone caproate
weekly injection, 250 mg until 34 weeks gestation

Active Comparator: 4
short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
Drug: vaginal progesterone
daily vaginal progesterone 200 mg until 34 weeks gestation.




Primary Outcome Measures :
  1. efficacy [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. comfort of use and consequently of that compliance [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809939


Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Tal Biron-Shental, MD Meir Medical Center, Israel, Affiliated to Tel Aviv University

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00809939     History of Changes
Other Study ID Numbers: 0129-08-MMC Ver:1
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by Meir Medical Center:
preterm delivery
short cervical length
progesterone

Additional relevant MeSH terms:
Progesterone
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists