To determine if intrauterine vesico-amniotic shunting for fetal bladder outflow obstruction (LUTO), compared to conservative care improves perinatal mortality and renal function Secondary - to determine if shunting for fetal LUTO improves perinatal morbidity and the safety and long-term efficacy of shunting.
An international multi-centre RCT with a comprehensive cohort design. Eligible pregnancies were those with a singleton, male fetus with ultrasound evidence of LUTO and no other major congenital or structural anomalies. Assessment of eligible pregnancies included fetal renal function (ultrasound +/− fetal urinalysis), a detailed ultrasound examination to exclude other co-existing anomalies (and ideally fetal karyotyping). Following informed consent randomization was via computer to receive either a fetal vesico-amniotic shunt or continue with conservative management without a shunt. The primary outcome measures were perinatal mortality and serum creatinine at 6 weeks of age. Long-term follow-up of continence and assessment of childhood development and quality of life is planned at five years.
145 women were recruited to the study, 31 to the randomised arm (21.4%), 46 to the registry (31.7%) and 68 termination of pregnancy (46.9%). Of the 31 randomised pregnancies, 16 received a vesico-amniotic shunt and 15 conservative management. Overall outcomes in the randomised group were 39% alive at 28 days, 16% opted for termination of pregnancy after randomisation, 6% miscarriage 24 weeks and 36% neonatal death <28 days. Analysis for the primary outcome showed an improved odds ratio (OR) for perinatal survival with shunting, OR 4.00 (95% confidence intervals 1.11-14.35). Further data on analysis with stratification for maternal and fetal variables at diagnosis will be presented along with data from the registry patients.
Many women whose babies have LUTO opt for termination of pregnancy. LUTO amenable to treatment is a rare condition. Preliminary results show an improvement in perinatal survival in those fetuses who underwent vesicoamniotic shunting. Funding: HTA UK.
© 2012 Mosby, Inc. Published by Elsevier Inc. All rights reserved.