NCT04497532

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

March 20, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

July 29, 2020

Last Update Submit

March 3, 2021

Conditions

Polyhydramnios

Outcome Measures

Primary Outcomes (1)

  • Amniotic fluid index (AFI) after 2 weeks

    AFI as measured in ultrasound

    Assess AFI two weeks after diet initiation

Study Arms (2)

Control

NO INTERVENTION

Diet

EXPERIMENTAL
Other: Diet as suited for gestational diabetes mellitus

Interventions

Diet as suited for gestational diabetes mellitusOTHER

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

Diet

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polyhydramnios

Interventions

Diet

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Liliya Tamayev, MD

    Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liliya Tamayev, MD

CONTACT

+972532343882t_liki@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 4, 2020

Study Start

March 20, 2021

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share