Polyhydramnios
Conditions
Keywords
Amniodrainage, Pregnancy, Amniocentesis
Brief summary
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
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.
Interventions
DEVICESyringe aspiration
It consists of performing successive aspirations using a 50ml syringe connected to the needle by a flexible tube.
DEVICEWall suction
The tubing is connected to the centralized suction system by continuous vacuum, the value of the applied vacuum is 250mmHg
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maternal pain (Analogic visual scale) | After drainage |
Secondary
| Measure | Time frame |
|---|---|
| Duration of the drainage | After drainage |
| Uterine activity | After drainage |
| Volume of amniotic fluid drained | After drainage |
| Clinical Retroplacental Haematome | After drainage |
| Histological analysis of the placentas | After drainage |
| Recording of Foetal Heart Rate | After drainage |
Countries
France
Outcome results
None listed