Influence of Diet on Pregnancy With Polyhydramnios

NCT ID: NCT04497532

Last Updated: 2021-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-20

Study Completion Date

2022-12-20

Brief Summary

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

Detailed Description

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Conditions

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Polyhydramnios

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Diet

Group Type EXPERIMENTAL

Diet as suited for gestational diabetes mellitus

Intervention Type OTHER

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

Interventions

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Diet 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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Liliya Tamayev

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liliya Tamayev, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Central Contacts

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Liliya Tamayev, MD

Role: CONTACT

+972532343882

Other Identifiers

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0152-19-WOMC

Identifier Type: -

Identifier Source: org_study_id

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