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Not yet recruitingNCT07067593Updated Jul 16, 2025

Amnioreduction in Polyhydramnios

An observational study in Polyhydramnios, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
28
Sex
Female
01

Study summary

The aim of this work is to review the indications, procedural complications and outcomes of amnioreduction in pregnancies complicated by polyhydramnios.

Read the 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

02

Conditions studied

  • Polyhydramnios

Keywords

  • Amnioreduction
  • Polyhydramnios
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In context

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All pregnant women between 24 to 38 weeks attending Fetal Medicine Unit at Women's health hospital for antenatal care or admitted due to antepartum hemorrhage or for scheduled surgery and meeting the inclusion criteria are counseled to participate in our study after informed consent. sample size will be devided into 2 groups:

Group 1 : patients with Amnioreduction Group 2 : patients with conservative management (without amnioreduction)

Inclusion criteria

  • Pregnant women 20- 38 weeks
  • Patients with polyhydramnios

Exclusion criteria

Exclusion criteria:

  • Lethal fetal anomalies
  • Pre labor rupture of membranes
  • Placental separation
  • Chorioamnionitis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
28 participants (estimated)
Patient registry
No

Groups and cohorts

  • Amnioreduction
  • Conservative
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What researchers measure

Primary outcomes

  1. Gestational age at delivery

    Determine Gestational age at delivery in polyhydramnios patients . Increased age is good.

    Time frame: 4 months

  2. Rate of PROM

    Number of cases developed PROM

    Time frame: 4 months

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Study locations

1 site
  • Women's Health Hospital
    Asyut, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07067593
Lead sponsor
Assiut University
Responsible party
Mohamed Gamal M.fekry (Lecturer obstetric and gynecology, Specialist Urogynecology, Assiut University) — Principal investigator
First posted
Jul 16, 2025
Start date
Aug 2025 (estimated)
Primary completion
Jan 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Jul 16, 2025

Study contacts

Mohamed Fekry, PhD
Contact
mohamedbeethoven2040@gmail.com
0882312388

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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