Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236340
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2005-10-11
Brief Title:
Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios A Prospective Randomized Study
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios A Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 needles tip didnt vary during the procedure
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 patients 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 needles tip didnt vary during the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None