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17-Alpha hydroxyprogesterone in Multiple pregnancies to Prevent Handicapped InfAnts

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To investigate the hypothesis that prophylactic administration of 17alpha hydroxyprogesterone (17OHPC) will reduce the incidence of thecomposite neonatal morbidity of neonates by reducing the early pretermbirth rate in twin pregnancies. The composite morbidity rate afterearly preterm delivery between 24-27, 28-32 and 32-34 weeks ofgestation is respectively 77%, 35% and 12%. After 34 weeks it sharplydeclines to less than 2%. The incidence of preterm birth in twins inthese gestational periods is 1.8, 5.2 and 7.4%, respectively. As aresult of this early delivery finally about 8% of the children willdie, 6% will remain severely disabled and 20% will be moderatelydisabled.
At present, no general accepted strategy for prevention of pretermbirth in multiple pregnancies exits. Prophylactic administration of17OHPC that proved to be effective in singleton pregnancies at highrisk 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.

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 severemorbidity). Secondary outcome measures are time to delivery, pretermbirth rate before 32 and 37 weeks, days of admission in neonatalintensive care unit, maternal morbidity, maternal admission days forpreterm labour and costs.

Power/ data analysis
Analysis will be by intention to treat. The effectiveness ofprogesterone versus placebo will be assessed by calculating relativerisks and 95% confidence intervals. Assuming a decrease of theincidence of bad neonatal outcome from 14.9% without to 7.9% withprogesterone, using a two sided test with an alpha 0.05 and a beta of0.8, 700 women (350 per arm) are needed in the study.

Time schedule
Three months for logistics of the study set up, 30 months forrecruitment and seven months for the final data collection andevaluation.

Dr. B.W. Mol, gynaecologist, AMC Amsterdam
Dr. H.W. Bruinse, gynaecologist, UMC Utrecht

Health Technology Assessment
Dr. E. Birnie, AMC Amsterdam
Drs. S.M.C. Vijgen, AMC

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