Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-28 @ 1:31 AM
Study NCT ID:
NCT07067593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amnioreduction in Polyhydramnios
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Benefits and Risks of Amnioreduction for Management of Pregnant Women With Polyhydramnios
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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:
The aim of this work is to review the indications, procedural complications and outcomes of amnioreduction in pregnancies complicated by polyhydramnios.
Detailed Description:
Polyhydramnios is the presence of excessive amniotic fluid in the amniotic sac and it's prevalence reaches 2% of all pregnancies . Polyhydramnios is diagnosed based on ultrasound criteria, as an amniotic fluid index (AFI) \>25 cm or maximal vertical pocket \> 8 cm . There is a recognized association of polyhydramnios and adverse pregnancy outcomes, including perinatal death, fetal abnormality and preterm birth . Management of the pregnancy can be problematic, particularly in severe cases, due to issues surrounding maternal discomfort and the risk of preterm birth. Amnioreduction, widely used in the management of polyhydramnios, is an option available to palliate maternal symptomatology and potentially prolong the pregnancy . Previous publications have shown a reduction in the risk for premature rupture of membranes and preterm labor decrease, placental perfusion improvement, and relief of maternal discomfort following amnioreduction
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: