National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

MFMU Network Randomized Clinical Trial of
17 alpha-Hydroxyprogesterone Caproate for Prevention
of Preterm Birth in High Risk Women

Related publications and presentations

Objective

To test the hypothesis that administration of 17 alpha-hydroxyprogesterone caproate initiated before 21 weeks gestation will reduce the risk of preterm birth in women who have previously experienced an early spontaneous preterm delivery.

Conclusion

Weekly injections of 17 alpha-hydroxyprogesterone caproate resulted in a substantial reduction in the rate of recurrent preterm delivery.

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
• 16⁰ 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 36⁶ 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