Leiden Factor V Deficiency,PreeclampsiaNCT03871764
Prediction of Outcome in Severe Preeclampsia
An observational study of Leiden Factor V Deficiency,Preeclampsia and Doppler Examination, run by Cairo University.
Trial summary
this summary studied the predictive values of factor V Leiden mutation , doppler indices , placental pathology to unfavorable fetal and maternal outcomes Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Leiden Factor V Deficiency,Preeclampsia, Doppler Examination, Palental Pathology
- What is being tested?
- blood sample , doppler of uterine vessel and placenta
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to Apr 2017
- How long will I take part?
- 7 Days
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women with preeclampsia in 3rd trimester. Singleton pregnancy. Accurate gestational age confirmed by last menstrual period or sonography before 20 weeks.
Who may be able to join
- Exclusion Criteria:Twin pregnancy. Fetal congenital anomalies. Diabetic patient, impaired renal function. Any medical disorders even that HTN. Any placental pathology,Autoimmune diseases. Women with uterine activity or clinical emergencies with maternal hemodynamic instability or an indication for immediate termination of pregnancy.
- -
Who cannot join
None listed.
About this study
Official title: Relation of 3rd Trimester Uterine Artery Doppler Flow Velocimetry Indices, Factor V Leiden Mutation and Placental Pathology to the Severity of Preeclampsia
this summary studied the predictive values of factor V Leiden mutation , doppler indices , placental pathology to unfavorable fetal and maternal outcomes
Read the detailed description
leiden mutation is activated protein C resistance with hypercoagulable states and increased thrombotic risk. 99 % are heterozygous and 1 % is homozygous , very rare cases are psoudohomozygous with factor V deficiency. relation to this mutation was studied in severe preeclamptic patients. doppler indices of uterine arteries , increased pulsetility index or unilateral or bilateral uterine artery notch and placental pathology were studied.
- Being tested
- blood sample , doppler of uterine vessel and placenta
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample , doppler of uterine vessel and placentaDiagnostic test
blood sample for factor V and doppler examination of uterine arteries , placenta pathology post partum
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients develop abruption placenta, intrauterine growth retardation or delivered premature
placental abruption, prematurity, IUGR
Measured: within 12 wks from diagnosis of severe preeclampsia
percentage of fetuses and neonates complicated with intrauterine fetal death or need admission to incubator
IUFD, admission to neonatal IUC
Measured: from diagnosis of severe preeclampsia till one week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Dec 2015
- Primary completion30 Sep 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leiden Factor V Deficiency,PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olfat Nooh Riad Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871764
- Sponsor's protocol ID
- 019002
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 12 Mar 2019
- 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 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of 3rd Trimester Uterine Artery Doppler Flow Velocimetry Indices, Factor V Leiden Mutation and Placental Pathology to the Severity of Preeclampsia
- ClinicalTrials.gov ID
- NCT03871764
- Acronym / sponsor ID
- 019002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 12 Mar 2019 (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.
this summary studied the predictive values of factor V Leiden mutation , doppler indices , placental pathology to unfavorable fetal and maternal outcomes
Detailed description
leiden mutation is activated protein C resistance with hypercoagulable states and increased thrombotic risk. 99 % are heterozygous and 1 % is homozygous , very rare cases are psoudohomozygous with factor V deficiency. relation to this mutation was studied in severe preeclamptic patients. doppler indices of uterine arteries , increased pulsetility index or unilateral or bilateral uterine artery notch and placental pathology were studied.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with preeclampsia in 3rd trimester. Singleton pregnancy. Accurate gestational age confirmed by last menstrual period or sonography before 20 weeks.
Key inclusion criteria (2 listed)
- Exclusion Criteria:Twin pregnancy. Fetal congenital anomalies. Diabetic patient, impaired renal function. Any medical disorders even that HTN. Any placental pathology,Autoimmune diseases. Women with uterine activity or clinical emergencies with maternal hemodynamic instability or an indication for immediate termination of pregnancy.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| blood sample , doppler of uterine vessel and placentablood sample for factor V and doppler examination of uterine arteries , placenta pathology post partum | Diagnostic test | – |
Primary outcome
percentage of patients develop abruption placenta, intrauterine growth retardation or delivered premature
Time frame: within 12 wks from diagnosis of severe preeclampsia
placental abruption, prematurity, IUGR
percentage of fetuses and neonates complicated with intrauterine fetal death or need admission to incubator
Time frame: from diagnosis of severe preeclampsia till one week after delivery
IUFD, admission to neonatal IUC
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 12 Mar 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiden Factor V Deficiency,Preeclampsia and Doppler Examination, run by Cairo University.
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 0 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 12 Mar 2019. 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?
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?
percentage of patients develop abruption placenta, intrauterine growth retardation or delivered premature (time frame: within 12 wks from diagnosis of severe preeclampsia). The study lists 2 primary outcomes in all. 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 12 Mar 2019.