PreeclampsiaNCT02541110
Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler
An observational study of Preeclampsia and IUGR, run by Kasr El Aini Hospital.
Trial summary
Second trimester homocysteine \& uterine artery doppler will be assessed\& the cases will be followed up till delivery for development of preeclampsia, IUGR(intra-uterine growth retardation) \& other obstetric complications. 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
- Preeclampsia, IUGR
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Feb 2016
- 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: Spontaneous pregnancies with no risk factors
Who may be able to join
- spontaneous pregnancies with no risk factors
Who cannot join
- multiple pregnancies
- non intact renal function
- hypertension
- diabetes
- folic acid supplements
- antifolate drugs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Second Trimester Maternal Serum Homocysteine Level & Uterine Artery Doppler for Prediction of Preeclampsia , Intra-Uterine Growth Retardation (IUGR) & Other Obstetric Complications
Second trimester homocysteine \& uterine artery doppler will be assessed\& the cases will be followed up till delivery for development of preeclampsia, IUGR(intra-uterine growth retardation) \& other obstetric complications.
Read the detailed description
Spontaneous pregnancies with no risk factors will be included. Fasting plasma total homocysteine level samples will be collected between 15th \& 19th weeks.
Uterine artery doppler between 18th \& 22nd weeks.
Method 1: Screen positive cases will be considered if homocysteine level above 6.3umol/l
Method 2: Screen positive cases will be considered if they had bilateral notches and a mean resistivity index (RI) above 0.55, or unilateral notches and a mean RI above 0.65, or absence of notches and a mean RI above 0.7.
Method 3: Screen positive cases will be considered if they had bilateral notches and a mean RI above 0.55, or unilateral notches and a mean RI above 0.65, or absence of notches and a mean RI above 0.7 combined with homocysteine cut off value of 6.3umol / l.
- Conditions
- Preeclampsia, IUGR
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pregnants who developed preeclampsia, those who developed IUGR alone and those who developed other obstetric complications as preterm labour and placental abruption
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, suzy abdelaziz Abdelhamid, Kasr El Aini Hospital
- Investigators
- suzy abdelaziz, M.D., Principal investigator, kasrelaini hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541110
- Sponsor's protocol ID
- Obgyn. .
- Status last verified
- Aug 2015
- First submitted
- 31 Aug 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Trimester Maternal Serum Homocysteine Level & Uterine Artery Doppler for Prediction of Preeclampsia , Intra-Uterine Growth Retardation (IUGR) & Other Obstetric Complications
- ClinicalTrials.gov ID
- NCT02541110
- Acronym / sponsor ID
- Obgyn. .
- Conditions
- Preeclampsia, IUGR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 4 Sep 2015 (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.
Second trimester homocysteine \& uterine artery doppler will be assessed\& the cases will be followed up till delivery for development of preeclampsia, IUGR(intra-uterine growth retardation) \& other obstetric complications.
Detailed description
Spontaneous pregnancies with no risk factors will be included. Fasting plasma total homocysteine level samples will be collected between 15th \& 19th weeks.
Uterine artery doppler between 18th \& 22nd weeks.
Method 1: Screen positive cases will be considered if homocysteine level above 6.3umol/l
Method 2: Screen positive cases will be considered if they had bilateral notches and a mean resistivity index (RI) above 0.55, or unilateral notches and a mean RI above 0.65, or absence of notches and a mean RI above 0.7.
Method 3: Screen positive cases will be considered if they had bilateral notches and a mean RI above 0.55, or unilateral notches and a mean RI above 0.65, or absence of notches and a mean RI above 0.7 combined with homocysteine cut off value of 6.3umol / l.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Spontaneous pregnancies with no risk factors
Key inclusion criteria (1 listed)
- spontaneous pregnancies with no risk factors
Key exclusion criteria (6 listed)
- multiple pregnancies
- non intact renal function
- hypertension
- diabetes
- folic acid supplements
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
Number of pregnants who developed preeclampsia, those who developed IUGR alone and those who developed other obstetric complications as preterm labour and placental abruption
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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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.
suzy abdelaziz, M.D. principal investigator
kasrelaini hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and IUGR, run by Kasr El Aini Hospital.
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 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: status not confirmed, as of the sponsor's last update on 4 Sep 2015. 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 suzy abdelaziz, M.D. (01003726195, suzyabdelaziz92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pregnants who developed preeclampsia, those who developed IUGR alone and those who developed other obstetric complications as preterm labour and placental abruption (time frame: 4 months). 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 Sep 2015.