OP24.09: Proposal for open randomized trial comparing perinatal outcome following expectant management versus amnioinfusion in PPROM < 25 weeks with persistent oligohydramnios (amnioinfusion initiative)

Authors


Background

Early spontaneous preterm premature rupture of membranes (PPROM) is associated with high perinatal mortality. Due to pulmonary hypoplasia and preterm delivery, mortality exceeds 60% when PPROM occurs prior to 24 weeks. When oligohydramnios persists, it may rise to 90%. Morbidity in survivors is also significant. In uncontrolled series, serial amnioinfusions, which have acceptable invasiveness and are of limited complexity, mortality was reduced to 60%.

Aim of the study

We propose an open, multicenter randomized trial comparing perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions.

Inclusion criteria

Single pregnancy, early spontaneous PPROM < 24.3 weeks, oligohydramnios (deepest vertical pocket < 2 cm) for at least 4 days and no longer than 15 days at enrollment. The study is open and will be run through a dedicated password-protected website, and with a minimal number of outcome measures. Primary outcome: Survival till discharge from the NICU. Secondary outcomes: Latency time from PPROM to delivery, gestational age at birth, indication for delivery, number of days of ventilatory support, serious neurologic morbidity, neonatal sepsis prevalence, need for oxygen at 36 weeks post-conception.

Statistics

38 patients in each arm are necessary to show an increase in neonatal survival from 10% to 40%, with a power of 0.80 and alpha = 0.05. An interim analysis after recruitment of 75% of the study population will be held in order to re-calculate sample size according to the difference between the groups in latency time as the main secondary outcome.

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