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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women | Other | 47 single foetal pregnancies and 33 twin pregnancies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Syringe aspiration | Device | It consists of performing successive aspirations using a 50ml syringe connected to the needle by a flexible tube. |
|
| Measure | Description | Time Frame |
|---|---|---|
| maternal pain (Analogic visual scale) | After drainage |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of amniotic fluid drained | After drainage | |
| Duration of the drainage | After drainage | |
| Uterine activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franck Perrotin, MD PhD | Institut National de la Santé Et de la Recherche Médicale, France | Study Director |
| Andrea Wagner, MD | Institut National de la Santé Et de la Recherche Médicale, France | Principal Investigator |
| Gilles Body, MD PhD | CHU Bretonneau TOURS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bretonneau | Tours | Centre-Val de Loire | 37000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14770396 | Background | Leung WC, Jouannic JM, Hyett J, Rodeck C, Jauniaux E. Procedure-related complications of rapid amniodrainage in the treatment of polyhydramnios. Ultrasound Obstet Gynecol. 2004 Feb;23(2):154-8. doi: 10.1002/uog.972. | |
| 11438952 | Background | Jauniaux E, Holmes A, Hyett J, Yates R, Rodeck C. Rapid and radical amniodrainage in the treatment of severe twin-twin transfusion syndrome. Prenat Diagn. 2001 Jun;21(6):471-6. doi: 10.1002/pd.96. |
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| ID | Term |
|---|---|
| D006831 | Polyhydramnios |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Wall suction | Device | The tubing is connected to the centralized suction system by continuous vacuum, the value of the applied vacuum is 250mmHg |
|
| After drainage |
| Recording of Foetal Heart Rate | After drainage |
| Clinical Retroplacental Haematome | After drainage |
| Histological analysis of the placentas | After drainage |
| 7970458 | Background | Elliott JP, Sawyer AT, Radin TG, Strong RE. Large-volume therapeutic amniocentesis in the treatment of hydramnios. Obstet Gynecol. 1994 Dec;84(6):1025-7. |
| 9464739 | Background | Dolinger MB, Donnenfeld AE. Therapeutic amniocentesis using a vacuum bottle aspiration system. Obstet Gynecol. 1998 Jan;91(1):143-4. doi: 10.1016/s0029-7844(97)00584-x. |