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Prevention of handicap in children by reducing the preterm birth rate in twin pregnancy: a randomised clinical trial comparing profylactic progesterone administration with placebo

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OBJECTIVE: To investigate the hypothesis that prophylactic administration of 17 alpha hydroxyprogesterone (17OHPC) will reduce the incidence of the composite neonatal morbidity of neonates by reducing the early preterm birth rate in twin pregnancies. The composite morbidity rate after early preterm delivery between 24-27, 28-32 and 32-34 weeks of gestation is respectively 77%, 35% and 12%. After 34 weeks it sharply declines to less than 2%. The incidence of preterm birth in twins in these gestational periods is 1.8, 5.2 and 7.4%, respectively. As a result of this early delivery finally about 8% of the children will die, 6% will remain severely disabled and 20% will be moderately disabled. At present, no general accepted strategy for prevention of preterm birth in multiple pregnancies exits. Prophylactic administration of 17OHPC that proved to be effective in singleton pregnancies at high risk for preterm delivery is as yet not advised. STUDY DESIGN: Prospective randomised placebo controlled trial. STUDY POPULATION: Women with a twin pregnancy (bichorionic or monochorionic)at a gestational age between 15 and 20 weeks of gestation. INTERVENTION: Weekly 250 mg 17 OHPC i/m injections from 16-20 weeks up to 36 weeks of gestation versus placebo. OUTCOME MEASURES: Primary outcome is composite bad neonatal condition (death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. POWER/ DATA ANALYSIS: Analysis will be by intention to treat. The effectiveness of progesterone versus placebo will be assessed by calculating relative risks and 95% confidence intervals. Assuming a decrease of the incidence of bad neonatal outcome from 14.9% without to 7.9% with progesterone, using a two sided test with an alpha 0.05 and a beta of 0.8, 700 women (350 per arm) are needed in the study. TIME SCHEDULE: Three months for logistics of the study set up, 30 months for recruitment and 7 month for the final data collection and evaluation.

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Projectnummer:
62200019
Looptijd: 100%
Looptijd: 100 %
2006
2010
Onderdeel van programma:
Projectleider en penvoerder:
Prof. dr. H.W. Bruinse
Verantwoordelijke organisatie:
Universitair Medisch Centrum Utrecht