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Completed

NCT Number: NCT00236340

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

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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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bretonneau

Tours, Centre-Val de Loire, 37000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Syringe aspiration

Device

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

Wall suction

Device

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

Primary outcomes

  1. maternal pain (Analogic visual scale)

    Time frame: After drainage

Secondary outcomes

  1. Volume of amniotic fluid drained

    Time frame: After drainage

  2. Duration of the drainage

    Time frame: After drainage

  3. Uterine activity

    Time frame: After drainage

  4. Recording of Foetal Heart Rate

    Time frame: After drainage

  5. Clinical Retroplacental Haematome

    Time frame: After drainage

  6. Histological analysis of the placentas

    Time frame: After drainage

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

DRAINAGE AMNIOTIQUE A LA SERINGUE OU PAR ASPIRATION CONTINUE DANS LES HYDRAMNIOS SYMPTOMATIQUES. ETUDE PROSPECTIVE RANDOMISEE.

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Oct 12, 2005
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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