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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Meir Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00809939
First Posted: December 17, 2008
Last Update Posted: August 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose

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 Intervention Phase
Pregnancy Drug: 17 alfa hydroxyprogesterone caproate Drug: natural progesterone Drug: vaginal progesterone Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • efficacy [ Time Frame: 3 years ]

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

Estimated Enrollment: 800
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00809939     History of Changes
Other Study ID Numbers: 0129-08-MMC Ver:1
First Submitted: December 16, 2008
First Posted: December 17, 2008
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