HealthyNCT00613210
Sonographic Prediction of Preterm Delivery Between 24-34 Weeks of Gestation
An observational study of Healthy, run by Soroka University Medical Center.
Trial summary
to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and abnormal doppler of the uterin artery can predict preterm labor Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jun 2008
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women that visit a tetriary hospital for follow up
Who may be able to join
- pregnancy between 24-34 wees of gestation
Who cannot join
- lack prenatal care
- fetal malformations stractural or genetical
- plcenta previa
- cerclage
- women who underwent conization of cervix
- polyhydramnious
Show all 11Show fewer
- premature rupture of membranes
- induction of labor d/t medical condition preterm
- women with hypertension, diabetis or preeclampsia
- susp IUGR
- women with a chronic illness that may interupt pregnancy
About this study
to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and abnormal doppler of the uterin artery can predict preterm labor
- Conditions
- Healthy
- Keywords
- preterm delivery, shory cervix, amniotic fluid sludge, uterine artery doppler, singeltone, normal amniotic fluid index, without rupter of membranes, 24-34 weeks of gestation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | women without contraction at 24-34 weeks of gestation | |
| 2 | women without contractions between 24-34 weeks of gestation with a history of preterm labor | |
| 3 | women with preterm contractions 24-34 weeks of gestation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Limor Man, Principal investigator, soroka medical center sonar unit of obstetrics and gynecology departmentlimor man, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613210
- Sponsor's protocol ID
- SOR463907CTIL
- Other IDs
- 4639
- Status last verified
- Jan 2008
- First submitted
- 22 Jan 2008
- Last updated
- 12 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Prediction of Preterm Delivery Between 24-34 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT00613210
- Acronym / sponsor ID
- SOR463907CTIL
- Conditions
- Healthy
- Keywords
- preterm delivery, shory cervix, amniotic fluid sludge, uterine artery doppler, singeltone, normal amniotic fluid index, without rupter of membranes, 24-34 weeks of gestation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (estimated)
- First posted
- 12 Feb 2008 (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.
to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and abnormal doppler of the uterin artery can predict preterm labor
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –women without contraction at 24-34 weeks of gestation |
| 2 | – | –women without contractions between 24-34 weeks of gestation with a history of preterm labor |
| 3 | – | –women with preterm contractions 24-34 weeks of gestation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women that visit a tetriary hospital for follow up
Key inclusion criteria (1 listed)
- pregnancy between 24-34 wees of gestation
Key exclusion criteria (11 listed)
- lack prenatal care
- fetal malformations stractural or genetical
- plcenta previa
- cerclage
- women who underwent conization of cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2008.
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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.
Limor Man principal investigator
soroka medical center sonar unit of obstetrics and gynecology department
limor man, MD principal investigator
Soroka University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Soroka University 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 1 inclusion and 11 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 12 Feb 2008. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 12 Feb 2008.