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Progesterone Therapy for Preterm Labor Perinatal Conference April 14, 2006

Progesterone Therapy for Preterm Labor Perinatal Conference April 14, 2006. Prematurity – the problem. 1 in 8 babies born in the U.S is premature, 1300 babies/day, 500,000 babies/year Leading cause of neonatal death, approximately 75%

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Progesterone Therapy for Preterm Labor Perinatal Conference April 14, 2006

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  1. Progesterone Therapy for Preterm Labor Perinatal Conference April 14, 2006

  2. Prematurity – the problem • 1 in 8 babies born in the U.S is premature, 1300 babies/day, 500,000 babies/year • Leading cause of neonatal death, approximately 75% • Significant cause of birth-related short- and long-term morbidity

  3. Prematurity in Arkansas • In an average week, 93 babies are born preterm • 16 are born very preterm • In 1991 12.8% of births were preterm • In 2001 13.1% of births were preterm, 4,841 births • In 2000, hospital costs for infants with diagnosis related to prematurity estimated at $11.9 billion.

  4. Preterm labor and prematurity • Preterm labor accounts for 80% of all premature births • Preterm birth is the largest single cause of cerebral palsy

  5. Rick scoring system Calvin H et al, Am J Obstet Gynecol, 1994; 170:54

  6. Predicting preterm delivery • Papiernik, Creasy – scoring system • Cervical ultrasound • Screening for vaginal infections • Fetal fibronectin • Uterine activity monitoring

  7. Preventing preterm birth • Cervical cerclage – 5 randomized trial, benefit only to women with 3 or more losses in the second and early third trimester (Harger Obstet Gynecol 2002:100:1313)

  8. Preventing preterm birth • Tocolytic therapy – most studies show no reduction in morbidity or mortality but decreased likelihood of preterm delivery within 7 days (Gyetvai et al, Obstet Gynecol 1999;94:869)

  9. Preventing preterm birth • Antibiotics – bacterial vaginosis, no reduction in preterm delivery or other adverse outcomes (Carey, et al, NEJM 2000;342:534)

  10. Actions of progesterone • Inhibits formation of gap junctions in myometrial cells • In animal studies, decrease in plasma progesterone and an increase in estrogen preceding onset of labor • Low plasma progesterone levels in women who delivered preterm • Progesterone antagonists and an increased rate of labor onset

  11. Progesterone trials • Johnson 1975 – 17alpha-hydroxyprogesterone caproate, 0% vs 41% • Meta-analysis Goldstein, 1989, no effect • Meta-analysis Keirse, 1990, there was an effect • Hartikainen-Sorri, 1980, no effect in twins • Hauth 1983, active duty military population, no difference

  12. Randomized progesterone trials • Randomized 142 high risk singleton pregnancies, at least one previous preterm birth, prophylactic cervical cerclage and uterine malformation • Progesterone (100 mg) or placebo vaginal suppository, qHS, 24-34 weeks • Preterm birth 13.8% vs 28.5% in placebo • Decreased frequency of contractions with treatment da Fonseca et al, Am J Obstet Gynecol 2003;188:419

  13. Randomized progesterone trials • 19 centers • Prior preterm delivery • 16-20 weeks to 36 weeks • Randomized 2:1 to receive weekly injections of 250 mg 17P or placebo • Delivery <37 weeks, 36.3% vs 54.9% • Delivery <32 weeks, 11.4% vs 19.6% • Significantly lower rates of NEC, IVH, O2 Meis et al, NEJM 2003;348:2379

  14. Sub-analysis of effect based on prior gestational age at delivery • Women with a prior delivery <34 weeks benefited most from progesterone treatment. Spong et al, AJOG 2005;193:1127

  15. Meta-Analysis of progestational agents to prevent preterm birth • Sanchez-Ramos et al, Obstet Gynecol 2005;105:273. • 10 RCT’s • Treated groups had lower rates of preterm delivery and SGA • Concluded progestational agents and 17HP reduced incidence of preterm birth and low birth weight newborns.

  16. Cochrane Database of Systemic Reviews • Dodd JM, Flenady V, Cincotta R and Crowther CA • January 25, 2006 in Issue 1, 2006 • Concluded that there was a reduction in risk of preterm birth <37 and <34 weeks. • Decreased low birthweight and IVH • No difference in perinatal death • No other differences

  17. Safety of 17-alpha hydroxyprogesterone caproate • No androgenic activity • Animal studies reassuring • No increase in malformations

  18. Treatment recommendations • Prevention of preterm delivery and preterm labor based on prior history of preterm labor and delivery • Prior history of preterm rupture of membranes • Start treatment by 24 weeks until 36 weeks • Progesterone treatment not recommended as a tocolytic agent

  19. Will 17P treatment make a difference? • United States 2002 statistics • Estimates on single births to multiparous women • Prenatal care within first 4 months • Previous preterm birth • Recurrent spontaneous preterm birth • Reduction in preterm birth • Change in U.S. preterm birth rate from 12.1% to 11.8%, 2% reduction Petrini et al, Obstet Gynecol 2005;105:267

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