Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study

• DOI: 10.1002/uog.13258
• Publication Date: 2013-11-21T21:24:01Z
• Authors: D. Roberts; S. Vause; W. Martin; P. Green; S. Walkinshaw; L. Bricker; C. Beardsmore; N. Shaw; A. McKay; G. Skotny; P. Williamson; Z. Alfirevic
• Keywords: Amnioinfusion; Rupture of membranes

ABSTRACT Objective To assess short‐ and long‐term outcomes of pregnant women with very early rupture membranes randomized to serial amnioinfusion or expectant management, collect data inform a larger, more definitive clinical trial. Methods This was prospective non‐blinded controlled trial randomization stratified for pregnancies in which the ruptured between 16 + 0 19 6 weeks' gestation 20 23 minimize risk random imbalance gestational age distribution groups. Intention‐to‐treat analysis used. The study conducted four UK hospital‐based fetal medicine units (Liverpool Women's NHS Trust, St Mary's Hospital Manchester, Birmingham Foundation Trust Wirral University Hospitals Trust). participants were confirmed preterm prelabor at 24 gestation. Women multiple pregnancy, abnormality obstetric indication immediate delivery excluded. Participants randomly allocated either weekly transabdominal amnioinfusions if deepest pool amniotic fluid < 2 cm management until 37 Short‐term maternal, pregnancy neonatal child studied. Long‐term respiratory morbidity assessed using validated questionnaires 6, 12 18 months infant lung function test around age. Neurodevelopment Bayley Scales Infant Development, second edition (BSID‐II) corrected years. Results Fifty‐eight study. Two babies excluded from because termination lethal anomaly, leaving 56 (28 assigned 28 management) recruited 2002 2009. There no significant difference perinatal mortality (19/28 vs 19/28; relative ( RR ) 1.0 (95% CI , 0.70–1.43)) maternal morbidity. overall chance surviving without neurodevelopmental disability 4/56 (7.1%); 4/28 (14.3%) group 0/28 9.0 0.51–159.70)). Conclusions pilot found major differences outcomes. not designed show groups number survivors too small draw any conclusions about It does, however, signal that larger evaluate improvement healthy survival is needed. suggests that, appropriate funding, such feasible. Copyright © 2013 ISUOG. Published by John Wiley & Sons Ltd.