PreeclampsiaNCT02350036
Placental Protein 13 Serum Endoglin and Uterine Doppler Indeces as Predictors of Pre-eclampsia
An observational study of Preeclampsia, run by Cairo University at 1 site in Egypt.
Trial summary
50 pregnant females were divided in two groups, twenty five as a control group and twenty five as high risk group; they were subjected to uterine artery Doppler, measurement of maternal serum and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14 weeks of gestation, all pregnancies were followed… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- ultrasound monitoring
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Dec 2016
- How long will I take part?
- 9 Months
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women at 11 to 14 weeks of gestation
Who may be able to join
- pregnant women at 11 to 14 weeks of gestation
Who cannot join
- fetal anomalies other medical diseases as diabetes mellitus, renal or liver diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Serum Placental Protein 13 Serum Endoglin and Uterine Doppler Indeces as Predictors of Pre-eclampsia and Relation to Maternal and Neonatal Outcome
50 pregnant females were divided in two groups, twenty five as a control group and twenty five as high risk group; they were subjected to uterine artery Doppler, measurement of maternal serum and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14 weeks of gestation, all pregnancies were followed until 40 weeks for development of pre-eclampsia
Read the detailed description
50 pregnant females were divided in two groups, twenty five as a control group and twenty five as high risk group; they were subjected to uterine artery Doppler, measurement of maternal serum (pp-13) and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14 weeks of gestation, all pregnancies were followed until 40 weeks for development of pre-eclampsia
- Conditions
- Preeclampsia
- Being tested
- ultrasound monitoring
- Keywords
- Preeclampsia, placental protein 13, Uterine artery doppler
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound monitoringOther
Uterine artery Doppler assessment
| Study group | Role | What they receive |
|---|---|---|
| preeclmapsia | women developed preeclampsia. ultrasound monitoring and uterine artery Doppler Receives: Other: ultrasound monitoring | |
| control | women with normal blood pressure all through pregnancy. ultrasound monitoring and uterine artery Doppler Receives: Other: ultrasound monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of preeclampsia
Measured: 40 weeks pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350036
- Sponsor's protocol ID
- 125
- Status last verified
- Mar 2017
- First submitted
- 26 Jan 2015
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Serum Placental Protein 13 Serum Endoglin and Uterine Doppler Indeces as Predictors of Pre-eclampsia and Relation to Maternal and Neonatal Outcome
- ClinicalTrials.gov ID
- NCT02350036
- Acronym / sponsor ID
- 125
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, placental protein 13, Uterine artery doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Jan 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.
50 pregnant females were divided in two groups, twenty five as a control group and twenty five as high risk group; they were subjected to uterine artery Doppler, measurement of maternal serum and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14 weeks of gestation, all pregnancies were followed until 40 weeks for development of pre-eclampsia
Detailed description
50 pregnant females were divided in two groups, twenty five as a control group and twenty five as high risk group; they were subjected to uterine artery Doppler, measurement of maternal serum (pp-13) and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14 weeks of gestation, all pregnancies were followed until 40 weeks for development of pre-eclampsia
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preeclmapsia | – | Other: ultrasound monitoringwomen developed preeclampsia. ultrasound monitoring and uterine artery Doppler |
| control | – | Other: ultrasound monitoringwomen with normal blood pressure all through pregnancy. ultrasound monitoring and uterine artery Doppler |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women at 11 to 14 weeks of gestation
Key inclusion criteria (1 listed)
- pregnant women at 11 to 14 weeks of gestation
Key exclusion criteria (1 listed)
- fetal anomalies other medical diseases as diabetes mellitus, renal or liver diseases
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 |
|---|---|---|
| ultrasound monitoringUterine artery Doppler assessment | Other | control, preeclmapsia |
Primary outcome
development of preeclampsia
Time frame: 40 weeks pregnancy
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 21 Mar 2017.
Related trials for Preeclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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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
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Ahmed Maged principal investigator
Kasr Alainy medical school
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 Preeclampsia, run by Cairo University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 21 Mar 2017. 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 Egypt. 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?
development of preeclampsia (time frame: 40 weeks pregnancy). 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 21 Mar 2017.