Does Amniotic Fluid Index Affect the Fetal Cardiac Performance?

September 6, 2017 updated by: Hillel Yaffe Medical Center

Does the Amniotic Fluid Index Affect the Fetal Cardiac Performance?

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • H̱adera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All pregnant women attending the Hillel Yaffe Medical Center's OB/GYN clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Isolated Oligohydramnios
Fetuses with amniotic fluid index (AFI) equal or less than 5 cm
Other: Echocardiography
Imaging of fetal heart and amniotic fluid
Isolated Polyhydramnios
Fetuses with amniotic fluid index (AFI) more than 25 cm
Other: Echocardiography
Imaging of fetal heart and amniotic fluid
Control Group
Fetuses with normal amount of amniotic fluid
Other: Echocardiography
Imaging of fetal heart and amniotic fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal cardiac ventricles
Time Frame: One month
The width of the fetal cardiac ventricles will be measured and compared between all three groups
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational age
Time Frame: One month
Gestational age at delivery will be compared between the three groups
One month
Mode of delivery
Time Frame: One month
Mode of delivery will be compared between the three groups
One month
Birth weight
Time Frame: One month
Birth weight will be compared between the three groups
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Rinat Gabbay-Benziv, MD, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (Actual)

September 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-0037-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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