Clinical trial NCT00236340: Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios. A Prospective Randomized Study.
Official title: Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polyhydramnios
Keywords: Amniodrainage
Pregnancy
Amniocentesis
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2005-10-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: maternal pain (Analogic visual scale)
Secondary outcomes:
measure: Volume of amniotic fluid drained, duration of the drainage, uterine activity,frequency of significative alterations of FHR and histologic evidence of placental abruption.
Other outcomes:
Locations:
city: Tours
country: France
facility: CHU Bretonneau
state: Centre
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Franck Perrotin, MD PhD
role: STUDY_DIRECTOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Andrea Wagner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Bretonneau TOURS
name: Gilles Body, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.