Fetal Movement PerceptionNCT01308359
Use of Glucose and Saline for Fetal Movement Perception
A study testing IV glucose 5% and saline in people with Fetal Movement Perception, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to investigate the hypothesis that glucose administration increases fetal movement perception by the pregnant woman. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Movement Perception
- What is being tested?
- IV glucose 5% and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2012
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy parturients with singleton pregnancy during 3rd trimester
Who cannot join
- Any maternal medical condition (Diabetes, hypertension), multiple pregnancy, fetal anomaly, polyhydramnios
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Ariel Many, MD, 97236925633
Nadav Mishan, MD, 97236925633
About this study
Official title: Impact of Glucose Administration on Perception of Fetal Movements
The purpose of this study is to investigate the hypothesis that glucose administration increases fetal movement perception by the pregnant woman.
- Conditions
- Fetal Movement Perception
- Being tested
- IV glucose 5%, saline
- Keywords
- fetal movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV glucose 5%Drug
500 ml glucose 5% within 30 minutes
salineDrug
saline
| Study group | Role | What they receive |
|---|---|---|
| glucose 5% | Experimental | glucose 5% Receives: Drug: IV glucose 5% |
| saline | Active comparator | saline Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal movements as perceived by the mother
Effect of glucose versus saline infusion on the perception of fetal movements. the mother will count fetal movements that she feels one hour following saline/glucose infusion and report to the obstetrician in charge. The research aims to clarify whether glucose increases fetal movements.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Movement PerceptionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Ariel Many, MD, Principal investigator, Lis Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308359
- Sponsor's protocol ID
- TASMC-10-am-0512-CTIL
- Status last verified
- Mar 2011
- First submitted
- 14 Dec 2010
- Last updated
- 4 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Glucose Administration on Perception of Fetal Movements
- ClinicalTrials.gov ID
- NCT01308359
- Acronym / sponsor ID
- TASMC-10-am-0512-CTIL
- Conditions
- Fetal Movement Perception
- Keywords
- fetal movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 4 Mar 2011 (estimated)
- 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.
The purpose of this study is to investigate the hypothesis that glucose administration increases fetal movement perception by the pregnant woman.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glucose 5% | Experimental | Drug: IV glucose 5%glucose 5% |
| saline | Active comparator | Drug: salinesaline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy parturients with singleton pregnancy during 3rd trimester
Key exclusion criteria (1 listed)
- Any maternal medical condition (Diabetes, hypertension), multiple pregnancy, fetal anomaly, polyhydramnios
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 |
|---|---|---|
| IV glucose 5%500 ml glucose 5% within 30 minutes | Drug | glucose 5% |
| salinesaline | Drug | saline |
Primary outcome
fetal movements as perceived by the mother
Time frame: one hour
Effect of glucose versus saline infusion on the perception of fetal movements. the mother will count fetal movements that she feels one hour following saline/glucose infusion and report to the obstetrician in charge. The research aims to clarify whether glucose increases fetal movements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
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.
Ariel Many, MD principal investigator
Lis Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV glucose 5% and saline in people with Fetal Movement Perception, run by Tel-Aviv Sourasky 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 1 inclusion and 1 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 2011. 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 Ariel Many, MD (97236925633, many@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal movements as perceived by the mother (time frame: one hour). 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 2011.