Polyhydramnios Clinical Trial
Official title:
Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios. A Prospective Randomized Study.
To compare the efficiency and maternal and fetal tolerance of two techniques of amnioreduction used in cases of symptomatic second and third trimester polyhydramnios: syringe manual aspiration technique (S group) and continuous suction technique (C group) set to – 250 mmHg
Polyhydramnios is defined as more than 2 liters of amniotic fluid. Ultrasound diagnosis is
made either by measurement of a deepest vertical pocket exceeding 8 cm, or by use of an
amniotic fluid index (AFI) exceeding 25 cm. Potential complications of polyhydramnios are
preterm labor, premature rupture of membranes, altered utero-placental perfusion, and
maternal discomfort.
Amniodrainage has become an established technique to improve maternal comfort and reduce the
risks of severe polyhydramnios in both singleton and twin pregnancies, decreasing uterine
contractility, as well as over-stretching of membranes and uterus. It also acts on the
pathological processes of twin to twin transfusion syndrome.
Several techniques are used to reduce symptomatic polyhydramnios. Passive gravitational
drainage is long, does not allow to evacuate larger amounts of amniotic fluid and continuous
maternal and fetal monitoring is difficult. The standard syringe technique is often a source
of discomfort for both the patient and the operator. Continuous aspiration is faster and
limits patient's discomfort.
The aim of this study was to compare the efficiency and maternal and fetal tolerance of
these two latter techniques of amnioreduction.
A preliminary study permitted to assess the depression value created at the tip of the
needle during amniodrainage: the syringe aspiration technique showed large depression
variations from 0 to – 300 millimeters of mercury (mmHg). The continuous wall suction was
thus chosen to be set to – 250 mmHg: depression at the needle's tip didn't vary during the
procedure.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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