CClinicalTrials.gg
Status unknownNCT04497532Updated Mar 4, 2021

Influence of Diet on Pregnancy With Polyhydramnios

An interventional study of Diet as suited for gestational diabetes mellitus in Polyhydramnios, sponsored by Wolfson Medical Center. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-04.

Sponsored by Wolfson Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic fluid index in women with idiopathic polyhydramnios.

02

Conditions studied

  • Polyhydramnios
03

In context

Lead sponsor

Wolfson Medical Center is the lead sponsor of 113 studies on the registry; 16 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Pregnant women between 24-37 pregnancy weeks, singleton pregnancy, diagnosed with AFI at 95% or more by gestational age
  • Express their consent to participate in the study and try to make the recommended dietary change for at least two consecutive weeks from the moment the guidelines are given.
  • Without a medical indication for an immediate delivery

Exclusion criteria

Exclusion Criteria:

  • Medical recommendation for delivery within two weeks of diagnosis
  • Condition of non-idiopathic amniotic fluid: gestational or pre-gestational diabetes, fetal malformation, proof of fetal infection
  • Premature rupture or membranes
  • Twins pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • No intervention
    Control
  • Experimental
    Diet

    Other: Diet as suited for gestational diabetes mellitus

Interventions

  • OtherDiet as suited for gestational diabetes mellitus

    Diet that consists of complex carbohydrates, and a regimen that includes 6 meals per day, as tailored gor gestational diabetes.

06

What researchers measure

Primary outcomes

  1. Amniotic fluid index (AFI) after 2 weeks

    AFI as measured in ultrasound

    Time frame: Assess AFI two weeks after diet initiation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04497532
Lead sponsor
Wolfson Medical Center
Responsible party
Liliya Tamayev (Principal Investigator, Wolfson Medical Center) — Principal investigator
First posted
Aug 4, 2020
Start date
Mar 20, 2021 (estimated)
Primary completion
Dec 20, 2022 (estimated)
Completion
Dec 20, 2022 (estimated)
Last update
Mar 4, 2021

Study contacts

Liliya Tamayev, MD
Contact
t_liki@yahoo.com
+972532343882
Liliya Tamayev, MD
principal investigator · Wolfson Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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