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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-02-28

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

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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.

Conditions

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Polyhydramnios

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Pregnant Women

47 single foetal pregnancies and 33 twin pregnancies

Group Type OTHER

Syringe aspiration

Intervention Type DEVICE

It consists of performing successive aspirations using a 50ml syringe connected to the needle by a flexible tube.

Wall suction

Intervention Type DEVICE

The tubing is connected to the centralized suction system by continuous vacuum, the value of the applied vacuum is 250mmHg

Interventions

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Syringe aspiration

It consists of performing successive aspirations using a 50ml syringe connected to the needle by a flexible tube.

Intervention Type DEVICE

Wall suction

The tubing is connected to the centralized suction system by continuous vacuum, the value of the applied vacuum is 250mmHg

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No