ABSTRACT
OBJECTIVE: To evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour. DESIGN: Multicentre, randomised, double-blind, placebo-controlled trial. SETTING: Twenty-nine centres in Switzerland and Argentina. POPULATION: A total of 385 women with preterm labour (24(0/7) to 33(6/7) weeks of gestation) treated with acute tocolysis. METHODS: Participants were randomly allocated to either 200 mg daily of self-administered vaginal progesterone or placebo within 48 hours of starting acute tocolysis. MAIN OUTCOME MEASURES: Primary outcome was delivery before 37 weeks of gestation. Secondary outcomes were delivery before 32 and 34 weeks, adverse effects, duration of tocolysis, re-admissions for preterm labour, length of hospital stay, and neonatal morbidity and mortality. The study was ended prematurely based on results of the intermediate analysis. RESULTS: Preterm birth occurred in 42.5% of women in the progesterone group versus 35.5% in the placebo group (relative risk [RR] 1.2; 95% confidence interval [95% CI] 0.93-1.5). Delivery at <32 and <34 weeks did not differ between the two groups (12.9 versus 9.7%; [RR 1.3; 95% CI 0.7-2.5] and 19.7 versus 12.9% [RR 1.5; 95% CI 0.9-2.4], respectively). The duration of tocolysis, hospitalisation, and recurrence of preterm labour were comparable between groups. Neonatal morbidity occurred in 44 (22.8%) cases on progesterone versus 35 (18.8%) cases on placebo (RR: 1.2; 95% CI 0.82-1.8), whereas there were 4 (2%) neonatal deaths in each study group. CONCLUSION: There is no evidence that the daily administration of 200 mg vaginal progesterone decreases preterm birth or improves neonatal outcome in women with preterm labour.
Subject(s)
Birth Weight , Obstetric Labor, Premature/drug therapy , Premature Birth/prevention & control , Progesterone/therapeutic use , Progestins/therapeutic use , Administration, Intravaginal , Adult , Apgar Score , Double-Blind Method , Female , Humans , Indomethacin/therapeutic use , Infant , Infant Mortality , Infant, Newborn , Intensive Care Units, Neonatal/statistics & numerical data , Pregnancy , Pregnancy Trimester, Second , Pregnancy Trimester, Third , Receptors, Oxytocin/antagonists & inhibitors , Tocolytic Agents/therapeutic use , Young AdultABSTRACT
Investigation was done in children with acute leukemia in complete hematological remission. It was tested whether out-patient treatment by intramuscular administration of arabinosylcytosine (Ara-C) may obviate the continuous intravenous Ara-C regimen. Every therapy cycle lasted 5 days. Changes in peripheral blood cell counts after 5 days of continuous intravenous. Ara-C infusion against 5 days of intramuscular Ara-C application given every 12 h were tested. 129 cycles of intramuscular application and 11 cycles of intravenous application were evaluated. Evaluation was done by the Friedmanntest. There was a significant decrease in blood cell counts after intramuscular Ara-C treatment. When administered intramuscularly during the first cycle Ara-C was effective for at least 3 weeks, whereas after repeated cycles the decline of blood cells was only demonstrable for 14 days. A comparison of the effect between intravenous and intramuscular routes revealed similar results. No local side effects were noted when Ara-C was given intramuscularly.
