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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Meir Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00809939
First received: December 16, 2008
Last updated: August 27, 2011
Last verified: August 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comfort of use and consequently of that compliance [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00809939     History of Changes
Other Study ID Numbers: 0129-08-MMC Ver:1
Study First Received: December 16, 2008
Last Updated: August 27, 2011
Health Authority: Israel: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research

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
Pharmacologic Actions
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014