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Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate

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ClinicalTrials.gov Identifier: NCT00120640
Recruitment Status : Withdrawn (funding)
First Posted : July 18, 2005
Last Update Posted : September 19, 2012
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE July 11, 2005
First Posted Date  ICMJE July 18, 2005
Last Update Posted Date September 19, 2012
Study Start Date  ICMJE July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2005)
  • Delivery <37 weeks' gestation
  • Delivery <34 weeks' gestation
  • Delivery <32 weeks' gestation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00120640 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2005)
Neonatal outcomes
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 Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate
Official Title  ICMJE Not Provided
Brief Summary The goal of our research will be to determine the effectiveness of 17 alpha-hydroxyprogesterone caproate (17P) in the treatment of preterm delivery. Treatment with progesterone is emerging as the standard of care for prevention of preterm delivery in asymptomatic patients at high risk for preterm birth due to a prior preterm delivery. Our goal is to evaluate whether or not progesterone is also effective in reducing preterm birth in symptomatic patients.
Detailed Description

Preterm delivery remains one of the most important issues facing perinatal medicine today. In 1999, prematurity/low birthweight accounted for 4,304 neonatal deaths, reflecting a rate of neonatal mortality due to prematurity of 23.0 per 100,000 live births. Despite the extent of the problem, the exact etiology of preterm delivery is not completely understood. It is clear that many pathways are involved in preterm delivery, and that ultimately these must converge upon one final endpoint, which is likely related to progesterone. In the animal model progesterone withdrawal is clearly directly (rodent, rabbit) or indirectly (sheep) involved in the initiation of parturition, however the exact way in which progesterone works in humans is unclear. There has been a resurgence of interest in the association between progesterone and preterm delivery. Two recent trials have looked at the utility of progesterone in the prevention of preterm delivery in high-risk patients. In a multicenter trial reported in the New England Journal of Medicine in 2003, Meis et al, recruited 463 patients with a history of spontaneous preterm delivery and randomized them in a 2:1 ratio to intramuscular 17-hydroxyprogesterone vs. placebo from 16-20 weeks until 36 weeks. Treatment with 17P significantly reduced the risk of delivery at <37 weeks, <35 weeks, and <32 weeks.

The Yale Progesterone Study is a randomized, placebo-controlled trial of the use of 17 hydroxyprogesterone for the treatment of preterm labor. The design is similar to the Meis NEJM trial, except that the patients will be symptomatic with preterm labor, rather than asymptomatic with a history of preterm delivery. In addition to the therapeutic intervention planned, the researchers intend to collect specimens to assess for markers of PTD, both before and after treatment. In this way, the researchers can analyze which pathway of PTD is involved, and finally, the effect of progesterone on these markers can be assessed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Premature Birth
  • Premature Labor
Intervention  ICMJE Drug: 17 hydroxyprogesterone caproate intramuscular injections
Study Arms  ICMJE Not Provided
Publications *

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 18, 2012)
0
Original Enrollment  ICMJE
 (submitted: July 11, 2005)
375
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients in preterm labor as described above.
  • Patients with an accurately dated singleton gestation. Accurate dating is defined as estimated date of delivery (EDD) based on last menstrual period (LMP) dating (280 days after the first day of the LMP) confirmed by an ultrasound done before 20 weeks, which yields an EDD within 10 days of LMP dating. If the LMP is not available, the EDD must be based on 2 ultrasounds performed at least 2 weeks apart, which are concordant within 5 days of the same EDD.
  • Patients with their first presentation of preterm labor will be invited to participate.
  • Patients whose plan of management includes admission to the hospital and administration of antenatal steroids for fetal well being.

Exclusion Criteria:

  • Rupture of membranes
  • Major known fetal anomalies
  • Cervical dilation > 4 centimeters
  • Uterine anomalies
  • Cervical cerclage
  • Treatment during this pregnancy with progesterone after 14 weeks' gestation (use up to 14 weeks' gestation is permitted)
  • Previous admission for preterm labor
  • Contraindications to tocolysis, including fetal distress, chorioamnionitis, preeclampsia, hemodynamic instability
  • Coexisting maternal disease including hypertension requiring medical therapy, cancer, seizure disorder, thromboembolic disorders, liver disease. Patients treated with oral beta adrenergics for asthma are also excluded.
  • Age < 18 years
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00120640
Other Study ID Numbers  ICMJE HIC#27253
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anna K Sfakianaki, MD Yale University
Principal Investigator: Edmund F Funai, MD Yale University
PRS Account Yale University
Verification Date September 2012

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