High Risk PregnancyNCT00722085
Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.
An observational study of High Risk Pregnancy and Incompetent Cervix, run by Center For Maternal Fetal Medicine at 1 site in United States.
Trial summary
Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Risk Pregnancy, Incompetent Cervix, Cerclage
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to May 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients at CMFM
Who may be able to join
- Cerclage
- Pregnancy Outcome data available
- Neonatal Outcome data available
- Pre and Post Cerclage Cervical length measurements
- Hx of cervical procedures, if any, available
Who cannot join
- Cervical ultrasound picture(s) unacceptable
- Any missing maternal or fetal data as stated above
- Fetal anomaly
- Cervical dilation at time of cerclage
- Placental previa or abruption
- Preterm Labor
Trial locations and contacts
1 site in 1 country.
United States1 site
Center For Maternal Fetal Medicine
Las Vegas, Nevada, 89106
About this study
Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients.
Read the detailed description
177 patients were selected from a data base of 1890. 60 patients had sludge, 117 did not have sludge. Conclusion AF sludge on ultrasound had no association with increased risk of preterm delivery in patients with cerclage.
- Conditions
- High Risk Pregnancy, Incompetent Cervix, Cerclage, Amniotic Fluid Sludge, Gestation Age at Delivery.
- Keywords
- Amniotic Fluid Sludge, Cerclage, Ultrasound, Preterm Delivery, Neonatal
- Medical subject headings
- Uterine Cervical Incompetence, 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 |
|---|---|---|
| Observational | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF Sludge as a predictor of preterm delivery in cerclage patients
Measured: 7 years
Secondary outcomes (1)
Absence of AF Sludge as a predictor of preterm delivery in cerclage patients
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center For Maternal Fetal Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Laura A Gorski, D.O., Principal investigator, Center For Maternal Fetal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722085
- Sponsor's protocol ID
- 1096165
- Status last verified
- Jul 2008
- First submitted
- 23 Jul 2008
- Last updated
- 25 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.
- ClinicalTrials.gov ID
- NCT00722085
- Acronym / sponsor ID
- 1096165
- Conditions
- High Risk Pregnancy, Incompetent Cervix, Cerclage, Amniotic Fluid Sludge, Gestation Age at Delivery.
- Keywords
- Amniotic Fluid Sludge, Cerclage, Ultrasound, Preterm Delivery, Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Center For Maternal Fetal MedicineUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Jul 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.
Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients.
Detailed description
177 patients were selected from a data base of 1890. 60 patients had sludge, 117 did not have sludge. Conclusion AF sludge on ultrasound had no association with increased risk of preterm delivery in patients with cerclage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients at CMFM
Key inclusion criteria (5 listed)
- Cerclage
- Pregnancy Outcome data available
- Neonatal Outcome data available
- Pre and Post Cerclage Cervical length measurements
- Hx of cervical procedures, if any, available
Key exclusion criteria (6 listed)
- Cervical ultrasound picture(s) unacceptable
- Any missing maternal or fetal data as stated above
- Fetal anomaly
- Cervical dilation at time of cerclage
- Placental previa or abruption
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
AF Sludge as a predictor of preterm delivery in cerclage patients
Time frame: 7 years
1 secondary outcome
Absence of AF Sludge as a predictor of preterm delivery in cerclage patients
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 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.
Laura A Gorski, D.O. principal investigator
Center For Maternal Fetal Medicine
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 High Risk Pregnancy and Incompetent Cervix, run by Center For Maternal Fetal Medicine at 1 site in United States.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jul 2008. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
AF Sludge as a predictor of preterm delivery in cerclage patients (time frame: 7 years). 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 25 Jul 2008.