Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1694831206598.pdf (Georgia)
INTERNATIONAL MULTICENTRE RCT OF AMNIOINFUSION Fraser WD Université de Montréal, Montreal, Canada Sponsors: UTAH Medical Steering Committee •A serious and frequent neonatal condition associated with meconium staining of the amniotic fluid.
•2.0% to 18% of infants delivered through MSAF develop MAS Primary objective To determine if a policy of amnioinfusion (AI) for thick MSAF prevents : •Perinatal death •Moderate to severe Meconium Aspiration Syndrome Secondary objectives •To assess the effects of AI on composite indicators of neonatal and maternal morbidity Inclusion criteria •Singleton pregnancy, GA >36 weeks •Established labor, cephalic presentation •Thick meconium, •Cervical dilatation : 2 and 7 cm •Fetal status acceptable on > 30 minute EFM tracing •Consent documented on IRB approved form Exclusion criteria •Major fetal anomaly •Chorioamnionitis •Placenta praevia or recent vaginal bleeding •Known or suspected HIV, hepatitis B or C •Uterine overdistension •Previous uterine incision other than low transverse Randomization •Centralized •Computerised •Stratified by centre •Stratified by: Stratum I: less than 3 variable decelerations Stratum II: 3 variable decelerations Characteristics of AI fluid •Sterile room temperature saline •Bolus: 800 ml 2 ml/min X 40 min •Infusion continued at 2 ml/min •Maximum : 1500 ml Meconium Aspiration Syndrome •Respiratory distress, first 4 hrs requiring O2 •Moderate MAS •FIO2 40% or 48 hours •Severe MAS •Requiring mechanical ventilation Blindly adjudicated by 3 neonatologists Composite serious neonatal morbidity Composite Serious maternal morbidity •Uterine rupture •Antepartum hemorrhage •Hysterectomy •ICU admission •Maternal Death •Disseminated intravascular coagulation •Postpartum hemorrhage with transfusion Statistical analysis Analysis by intention to treat •Sample size : 982 per group •Expected Primary outcome, Control - 6% •Expected effect size - 0.5 •Power 0.85 Alpha 0.05 •Two interim analyses by DSMC.
They advised continuation of trial.

RESULTS Patient recruitment by country: 56 centres, 13 countries Treatment groups similar with respect to baseline variables: •Maternal age •Parity •Maternal Education •Gestational Age •BMI •Oxytocin use Proportion of AI performed in two groups Primary outcome Secondary Morbidity indicators Stratified analysis Conclusion: In women with thick meconium staining of the AF, amnioinfusion is NOT effective in preventing: –MAS –other serious neonatal morbidity.
Amnioinfusion does NOT decrease the risk of cesarean section in this population.

Conclusion: A planned secondary analysis of perinatal and maternal effects by stratum - (presence or absence of variable decels) : –No evidence of heterogeneity of effects accross strata.
Discussion Stratified analysis: primary Stratum - cesarean MAS with Abn CXR Fetal HRT – Stratum Cx dilatation and durlab Stratified by Hemisphere: Primary Complications Technique Fetal assessment Recusscitation Baseline characteristics Neonatal outcomes Stratified Caesarean delivery rate by stratum Primary Outcome by Hemisphere Abnormal FHR tracing requiring clinical intervention by stratum Labour characteristics Complication during AI Description of study intervention Co-interventions : fetal assessment Baseline Maternal Characteristics 1 Baseline charcterisitics of mother and baby