4.1 AMIPROM: A Pilot RCT on Serial Transabdominal Amnioinfusion Versus Expectant Management in Very Early PROM (ISRCTN 8192589)

Objective a randomised controlled multicentre pilot study to assess: -short- and long-term outcomes and data to inform a larger, definitive clinical trial. -the feasibility of recruitment and the retention through to long term follow up of participants with very early rupture of membranes. Participants Women with singleton pregnancies and confirmed preterm prelabour rupture of membranes between 16 +0 and 24 +0 weeks gestation. Women with fetal abnormality or obstetric indication for immediate delivery were excluded. Interventions Participants were randomly allocated to either serial weekly trans-abdominal amnioinfusions when the deepest pool of amniotic fluid was less Results 58 pregnancies recruited: 28 in the amnioinfusion group (AI); 28 in the expectant management group (exp); two post-randomisation exclusions. Overall perinatal survival in both groups was 17/56. Mean gestational age for AI group was 28.4 weeks vs. 29.8 weeks for exp (mean SD-1.4, 95% CI –0.2–1.5). One case of severe maternal sepsis requiring admission to HDU in the expectant management arm. Overall chance of surviving without long-term respiratory or neurodevelopmental disability is 7.1%; 4/28 (14%) in the AI group and 0/28 in the exp group (RR 9.0; 95% CI 0.51, 159.70). Conclusions The pilot findings do not suggest that clinicians should alter the current practise of expectantly managing rupture of membranes between 16 + 0 and 24 + 0 weeks of pregnancy. A larger definitive study to evaluate whether amnioinfusion has a cost-effective and acceptable role in improving healthy survival in very early rupture of membranes indicated. Funding NIHR HTA programme.