Status unknownNCT03277417Updated Sep 11, 2017

Does Amniotic Fluid Index Affect the Fetal Cardiac Performance?

An observational study in Oligohydramnios and Polyhydramnios, sponsored by Hillel Yaffe Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-11.

Sponsored by Hillel Yaffe Medical Center · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 90
Ages: 18 Years and older
Sex: Female

Study summary

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

Conditions studied

Oligohydramnios
Polyhydramnios

Browse trials for

Oligohydramnios 24

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Sampling method: Probability sample

Study population

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

Inclusion criteria

Gestational age 24-42 weeks
Singleton pregnancies

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 90 participants (estimated)
Patient registry: No

Groups and cohorts

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

OtherEchocardiography
Imaging of fetal heart and amniotic fluid

What researchers measure

Primary outcomes

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

Secondary outcomes

Gestational age
Gestational age at delivery will be compared between the three groups
Time frame: One month
Mode of delivery
Mode of delivery will be compared between the three groups
Time frame: One month
Birth weight
Birth weight will be compared between the three groups
Time frame: One month

Study locations

1 site

Hillel Yaffe Medical Center
H̱adera, 38100, Israel
- Rinat Gabbay-Benziv, MD · Contact · rinatg@hy.health.gov.il

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03277417
Lead sponsor: Hillel Yaffe Medical Center
Responsible party: Sponsor
First posted: Sep 11, 2017
Start date: Sep 2017 (estimated)
Primary completion: Sep 2019 (estimated)
Completion: Sep 2019 (estimated)
Last update: Sep 11, 2017

Study contacts

Rinat Gabbay-Benziv, MD

Contact

rinatg@hy.health.gov.il

972-4-6304512

Rinat Gabbay-Benziv, MD

principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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