Does Amniotic Fluid Index Affect the Fetal Cardiac Performance?

NCT ID: NCT03277417

Last Updated: 2017-09-11

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

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-30

Study Completion Date

2019-09-30

Brief Summary

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To evaluate and compare fetal cardiac performance by fetal echocardiography and delivery outcome between fetuses with isolated oligohydramnios, normal amniotic fluid and polyhydramnios.

Detailed Description

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Conditions

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Oligohydramnios Polyhydramnios

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Isolated Oligohydramnios

Fetuses with amniotic fluid index (AFI) equal or less than 5 cm

Echocardiography

Intervention Type OTHER

Imaging of fetal heart and amniotic fluid

Isolated Polyhydramnios

Fetuses with amniotic fluid index (AFI) more than 25 cm

Echocardiography

Intervention Type OTHER

Imaging of fetal heart and amniotic fluid

Control Group

Fetuses with normal amount of amniotic fluid

Echocardiography

Intervention Type OTHER

Imaging of fetal heart and amniotic fluid

Interventions

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Echocardiography

Imaging of fetal heart and amniotic fluid

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gestational age 24-42 weeks
* Singleton pregnancies

Exclusion Criteria

* Fetal anatomical or chromosomal abnormality
* Known fetal cardiac defect
* Suspected fetal infection
* Suspected IUGR
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rinat Gabbay-Benziv, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Rinat Gabbay-Benziv, MD

Role: CONTACT

972-4-6304512

Facility Contacts

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Rinat Gabbay-Benziv, MD

Role: primary

Other Identifiers

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HYMC-0037-17

Identifier Type: -

Identifier Source: org_study_id

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