[Multicenter randomized trial of amnioinfusion].
Meconium staining of the amniotic fluid in labor is a frequent problem that is associated with an increase in the risk of neonatal and maternal morbidity. Amnioinfusion is a simple technique that is designed to prevent neonatal and maternal morbidity associated with meconium. Preliminary studies indicate that amnioinfusion is a promising approach to the prevention of such complications of labor. However, further research is required. The primary objective of this multi-centre randomized controlled study is to determine if amnioinfusion for thick meconium stained amniotic fluid results in a reduction in perinatal death or moderate to severe meconium aspiration syndrome. We will also assess the effects of amnioinfusion on other indicators of neonatal morbidity and on cesarean section. The study includes an evaluation of womens views on their childbirth experience and an economic evaluation of a policy of amnioinfusion The study will be achieved with the collaboration of approximately 50 obstetrical centres from across Canada, US, Europe, South America and South Africa. This multicentre trial will provide urgently needed information on the efficacy and effectiveness of amniofusion for the indication of meconium stained amniotic fluid.
Fraser
W
W
CHUQ-PSFA, Unité des Essais Cliniques, 10 rue de l'Espinay, local D1-724, Québec G1L 3L5, Canada. william.fraser@ogy.ulaval
Marcoux
S
S
Prendiville
W
W
Petrou
S
S
Hofmeyr
J
J
Reinharz
D
D
Goulet
C
C
Ohlsson
A
A
D000653:Amniotic Fluid / Q000502:physiology*; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000517:prevention & control*; D008470:Meconium; D008471:Meconium Aspiration Syndrome / Q000517:prevention & control; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic