NCT03277417

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

August 30, 2017

Last Update Submit

September 6, 2017

Conditions

OligohydramniosPolyhydramnios

Outcome Measures

Primary Outcomes (1)

  • Fetal cardiac ventricles

    The width of the fetal cardiac ventricles will be measured and compared between all three groups

    One month

Secondary Outcomes (3)

  • Gestational age

    One month

  • Mode of delivery

    One month

  • Birth weight

    One month

Study Arms (3)

Isolated Oligohydramnios

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

Other: Echocardiography

Isolated Polyhydramnios

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

Other: Echocardiography

Control Group

Fetuses with normal amount of amniotic fluid

Other: Echocardiography

Interventions

EchocardiographyOTHER

Imaging of fetal heart and amniotic fluid

Control GroupIsolated OligohydramniosIsolated Polyhydramnios

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Gestational age 24-42 weeks
  • Singleton pregnancies

You may not qualify if:

  • Fetal anatomical or chromosomal abnormality
  • Known fetal cardiac defect
  • Suspected fetal infection
  • Suspected IUGR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

OligohydramniosPolyhydramnios

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Rinat Gabbay-Benziv, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rinat Gabbay-Benziv, MD

CONTACT

972-4-6304512rinatg@hy.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 11, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)