PolyhydramniosNCT04497532
Influence of Diet on Pregnancy With Polyhydramnios
A study testing Diet as suited for gestational diabetes mellitus in people with Polyhydramnios, run by Wolfson Medical Center.
Trial summary
To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic fluid index in women with idiopathic polyhydramnios. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polyhydramnios
- What is being tested?
- Diet as suited for gestational diabetes mellitus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2021to 20 Dec 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women between 24-37 pregnancy weeks, singleton pregnancy, diagnosed with AFI at 95% or more by gestational age
- Express their consent to participate in the study and try to make the recommended dietary change for at least two consecutive weeks from the moment the guidelines are given.
- Without a medical indication for an immediate delivery
Who cannot join
- Medical recommendation for delivery within two weeks of diagnosis
- Condition of non-idiopathic amniotic fluid: gestational or pre-gestational diabetes, fetal malformation, proof of fetal infection
- Premature rupture or membranes
- Twins pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Influence of a Diet Suited for Gestational Diabetes on Amniotic Fluid Index in Patients Diagnosed With Idiopathic Polyhydramnios - a Randomized Controlled Trial
To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic fluid index in women with idiopathic polyhydramnios.
- Conditions
- Polyhydramnios
- Being tested
- Diet as suited for gestational diabetes mellitus
- Medical subject headings
- Polyhydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet as suited for gestational diabetes mellitusOther
Diet that consists of complex carbohydrates, and a regimen that includes 6 meals per day, as tailored gor gestational diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Diet | Experimental | Not described Receives: Other: Diet as suited for gestational diabetes mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amniotic fluid index (AFI) after 2 weeks
AFI as measured in ultrasound
Measured: Assess AFI two weeks after diet initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start20 Mar 2021 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyhydramniosStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Liliya Tamayev, Wolfson Medical Center
- Investigators
- Liliya Tamayev, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497532
- Sponsor's protocol ID
- 0152-19-WOMC
- Status last verified
- Mar 2021
- First submitted
- 29 Jul 2020
- Last updated
- 4 Mar 2021
- Results posted
- No
- 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 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Diet Suited for Gestational Diabetes on Amniotic Fluid Index in Patients Diagnosed With Idiopathic Polyhydramnios - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04497532
- Acronym / sponsor ID
- 0152-19-WOMC
- Conditions
- Polyhydramnios
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 20 Mar 2021 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 4 Aug 2020 (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 the effect of a diet that is suited for gestational diabetes mellitus on amniotic fluid index in women with idiopathic polyhydramnios.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Diet | Experimental | Other: Diet as suited for gestational diabetes mellitus |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women between 24-37 pregnancy weeks, singleton pregnancy, diagnosed with AFI at 95% or more by gestational age
- Express their consent to participate in the study and try to make the recommended dietary change for at least two consecutive weeks from the moment the guidelines are given.
- Without a medical indication for an immediate delivery
Key exclusion criteria (4 listed)
- Medical recommendation for delivery within two weeks of diagnosis
- Condition of non-idiopathic amniotic fluid: gestational or pre-gestational diabetes, fetal malformation, proof of fetal infection
- Premature rupture or membranes
- Twins pregnancy
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 |
|---|---|---|
| Diet as suited for gestational diabetes mellitusDiet that consists of complex carbohydrates, and a regimen that includes 6 meals per day, as tailored gor gestational diabetes. | Other | Diet |
Primary outcome
Amniotic fluid index (AFI) after 2 weeks
Time frame: Assess AFI two weeks after diet initiation
AFI as measured in ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Polyhydramnios
Not yet recruitingObservational study
Amnioreduction in Polyhydramnios
Polyhydramnios
Recruiting
"Fetal gRowth AbnorMality dEtection Trial"
Small for Gestational Age Infant, Large for Gestational Age Infant
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.
Liliya Tamayev, MD principal investigator
Wolfson Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Diet as suited for gestational diabetes mellitus in people with Polyhydramnios, run by Wolfson Medical Center.
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 3 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Liliya Tamayev, MD (+972532343882, t_liki@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amniotic fluid index (AFI) after 2 weeks (time frame: Assess AFI two weeks after diet initiation). 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 4 Mar 2021.