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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 11, 2005

Last Updated Date

April 18, 2007

Start Date ^ICMJE

January 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

maternal pain (Analogic visual scale)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00236340 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Polyhydramnios

Intervention ^ICMJE

Device: syringe aspiration
Device: Wall suction

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00236340

Other Study ID Numbers ^ICMJE

AMNIO-2000

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

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

Verification Date

October 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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