Influence of Diet on Pregnancy With Polyhydramnios | NCT04497532

Studies
Influence of Diet on Pregnancy With Polyhydramnios

NCT04497532

Sponsor

Wolfson Medical Center

Status

Unknown status

Last Update Posted

Mar 4, 2021Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Polyhydramnios

Interventions

Diet as suited for gestational diabetes mellitus

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2021Estimated

Primary Completion Date

Dec 20, 2022Estimated

Completion Date

Dec 20, 2022Estimated

First Submitted Date

Jul 29, 2020

First Submission Date that Met QC Criteria

Jul 29, 2020

First Posted Date

Aug 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2021

Last Update Posted Date

Mar 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention
Diet	Experimental		Other: Diet as suited for gestational diabetes mellitus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diet as suited for gestational diabetes mellitus	Other	Diet that consists of complex carbohydrates, and a regimen that includes 6 meals per day, as tailored gor gestational diabetes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amniotic fluid index (AFI) after 2 weeks	AFI as measured in ultrasound	Assess AFI two weeks after diet initiation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Liliya Tamayev, MD	Contact	+972532343882		t_liki@yahoo.com

Overall Officials

Name	Affiliation	Role
Liliya Tamayev, MD	Wolfson Medical Center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006831	Polyhydramnios

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004032	Diet

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided