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

This study has been completed.
Sponsor:
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00236340
First received: October 11, 2005
Last updated: April 18, 2007
Last verified: October 2005
  Purpose

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


Condition Intervention Phase
Polyhydramnios
Device: syringe aspiration
Device: Wall suction
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios. A Prospective Randomized Study.

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • maternal pain (Analogic visual scale)

Secondary Outcome Measures:
  • Volume of amniotic fluid drained, duration of the drainage, uterine activity,frequency of significative alterations of FHR and histologic evidence of placental abruption.

Estimated Enrollment: 80
Study Start Date: January 2002
Study Completion Date: February 2005
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00236340

Locations
France
CHU Bretonneau
Tours, Centre, France, 37000
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Franck Perrotin, MD PhD Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Andrea Wagner, MD Institut National de la Santé Et de la Recherche Médicale, France
Study Chair: Gilles Body, MD PhD CHU Bretonneau TOURS
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00236340     History of Changes
Other Study ID Numbers: AMNIO-2000
Study First Received: October 11, 2005
Last Updated: April 18, 2007
Health Authority: France: Ministry of Health

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Amniodrainage
Pregnancy
Amniocentesis

Additional relevant MeSH terms:
Polyhydramnios
Pregnancy Complications

ClinicalTrials.gov processed this record on October 16, 2014