OligohydramniosNCT03277417
Does Amniotic Fluid Index Affect the Fetal Cardiac Performance?
An observational study of Oligohydramnios and Polyhydramnios, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
To evaluate and compare fetal cardiac performance by fetal echocardiography and delivery outcome between fetuses with isolated oligohydramnios, normal amniotic fluid and polyhydramnios. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Oligohydramnios, Polyhydramnios
- What is being tested?
- Echocardiography
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2017to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: All pregnant women attending the Hillel Yaffe Medical Center's OB/GYN clinic
Who may be able to join
- Gestational age 24-42 weeks
- Singleton pregnancies
Who cannot join
- Fetal anatomical or chromosomal abnormality
- Known fetal cardiac defect
- Suspected fetal infection
- Suspected IUGR
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Rinat Gabbay-Benziv, MD, rinatg@hy.health.gov.il
About this study
Official title: 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.
- Conditions
- Oligohydramnios, Polyhydramnios
- Being tested
- Echocardiography
- Medical subject headings
- Oligohydramnios, Polyhydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
Imaging of fetal heart and amniotic fluid
| Study group | Role | What they receive |
|---|---|---|
| Isolated Oligohydramnios | Fetuses with amniotic fluid index (AFI) equal or less than 5 cm Receives: Other: Echocardiography | |
| Isolated Polyhydramnios | Fetuses with amniotic fluid index (AFI) more than 25 cm Receives: Other: Echocardiography | |
| Control Group | Fetuses with normal amount of amniotic fluid Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal cardiac ventricles
The width of the fetal cardiac ventricles will be measured and compared between all three groups
Measured: One month
Secondary outcomes (3)
Gestational age
Gestational age at delivery will be compared between the three groups
Measured: One month
Mode of delivery
Mode of delivery will be compared between the three groups
Measured: One month
Birth weight
Birth weight will be compared between the three groups
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligohydramniosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rinat Gabbay-Benziv, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277417
- Sponsor's protocol ID
- HYMC-0037-17
- Status last verified
- Sep 2017
- First submitted
- 30 Aug 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Amniotic Fluid Index Affect the Fetal Cardiac Performance?
- ClinicalTrials.gov ID
- NCT03277417
- Acronym / sponsor ID
- HYMC-0037-17
- Conditions
- Oligohydramnios, Polyhydramnios
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate and compare fetal cardiac performance by fetal echocardiography and delivery outcome between fetuses with isolated oligohydramnios, normal amniotic fluid and polyhydramnios.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isolated Oligohydramnios | – | Other: EchocardiographyFetuses with amniotic fluid index (AFI) equal or less than 5 cm |
| Isolated Polyhydramnios | – | Other: EchocardiographyFetuses with amniotic fluid index (AFI) more than 25 cm |
| Control Group | – | Other: EchocardiographyFetuses with normal amount of amniotic fluid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- All pregnant women attending the Hillel Yaffe Medical Center's OB/GYN clinic
Key inclusion criteria (2 listed)
- Gestational age 24-42 weeks
- Singleton pregnancies
Key exclusion criteria (4 listed)
- Fetal anatomical or chromosomal abnormality
- Known fetal cardiac defect
- Suspected fetal infection
- Suspected IUGR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyImaging of fetal heart and amniotic fluid | Other | Control Group, Isolated Oligohydramnios, Isolated Polyhydramnios |
Primary outcome
Fetal cardiac ventricles
Time frame: One month
The width of the fetal cardiac ventricles will be measured and compared between all three groups
3 secondary outcomes
Gestational age
Time frame: One month
Mode of delivery
Time frame: One month
Birth weight
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinat Gabbay-Benziv, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligohydramnios and Polyhydramnios, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rinat Gabbay-Benziv, MD (972-4-6304512, rinatg@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal cardiac ventricles (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.