MFMU Network Randomized Clinical Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in High Risk Women
Objective
To test the hypothesis that administration of 17 alpha-hydroxyprogesterone caproate for initiated before 21 weeks gestation will reduce the risk of preterm birth in women who have previously experienced an early spontaneous preterm delivery.
Conclusion
To be determined.
Clinical Centers
Magee Womens, Tennessee, Alabama, Wayne State, Cincinnati, Wake Forest, Chicago, Ohio State, Miami, UT-San Antonio, UT-Dallas, Utah, Thomas Jefferson, Brown, Columbia, UT-Houston, Case Western, UNC, Northwestern
Major Eligibility Criteria
Documented previous SPTD
16,0 to 20,6 weeks gestation
Informed consent
Groups:
Experimental = 1 ml IM with 250 17 a-hydroxyprogesterone caproate weekly
Placebo = 1 ml IM inert oil weekly
Sample size: Goal = 500 (334 active; 166 placebo)
Management Protocols
Coded medication:
1 ml IM with 250 mg 17 a-hydroxyprogesterone caproate weekly until 36,6 weeks gestation
1 ml IM inert oil weekly until 36,6 weeks gestation
Outcome Measures
Primary:Preterm delivery (<37 weeks gestation)
Secondary:
Tocolytic therapy
Cerclage placement
Salivary esteriol and progesterone trends
Neonatal morbidity and mortality
Timetable
As designed: Randomization: 12/97-03/99
Data collection: 12/97-11/99
Closeout/final analysis: 11/99-05/00
Source: New England Journal of Medicine