Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios. A Prospective Randomized Study.

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios. A Prospective Randomized Study.

Conditions
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Polyhydramnios

Intervention / Treatment
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* Device: syringe aspiration
* Device: Wall suction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with abdomen discumfort and ultrasound diagnosis of polyhydramnios (AFI>25cm) Single or twin pregnancies Exclusion Criteria: Multiple pregnancy (more than 3 fetuses) Maternal history of placental abruptio Fetus with IUGR Pregnancy complicated with pre-eclampsia Unability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: syringe aspiration|nan|
|Device: Wall suction|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal pain (Analogic visual scale) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of amniotic fluid drained, duration of the drainage, uterine activity,frequency of significative alterations of FHR and histologic evidence of placental abruption. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amniodrainage, Pregnancy, Amniocentesis