An interventional study of Syringe aspiration and Wall suction in Polyhydramnios, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Treatment
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.
Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
47 single foetal pregnancies and 33 twin pregnancies
Device: Syringe aspiration · Device: Wall suction
It consists of performing successive aspirations using a 50ml syringe connected to the needle by a flexible tube.
The tubing is connected to the centralized suction system by continuous vacuum, the value of the applied vacuum is 250mmHg
maternal pain (Analogic visual scale)
Time frame: After drainage
Volume of amniotic fluid drained
Time frame: After drainage
Duration of the drainage
Time frame: After drainage
Uterine activity
Time frame: After drainage
Recording of Foetal Heart Rate
Time frame: After drainage
Clinical Retroplacental Haematome
Time frame: After drainage
Histological analysis of the placentas
Time frame: After drainage
This study is completed, as verified in Oct 2005. You cannot join it, but the record below documents what was studied.
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Polyhydramnios
Institut National de la Santé Et de la Recherche Médicale, France