Pre-EclampsiaNCT03349671
Predictors of Intrauterine Growth Restriction
An observational study of Pre-Eclampsia, run by Assiut University at 1 site in Egypt.
Trial summary
The main objectives of modern antenatal care programs are to identify high risk pregnancies then to predict any possibility of adverse pregnancy outcome as early as possible. The earliest attempts to achieve this goal were possible with the introduction of ultrasound in obstetrical practice in the 1950s. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2018to Dec 2019
- 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: Women who meet the eligibility criteria of the study will be invited to participate and only those who will give agreement on the informed written consent.
Who may be able to join
- Pregnant female.
- Pregnant ± 22 to 26 weeks gestation
- Singleton pregnancy.
- Consenting to participate
Who cannot join
- Intrauterine fetal death
- Diagnosed to have Any congenital anomalies
- Symmetrical IUGR
- Established fetal compromise that necessitates delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Second Trimester Doppler Indices and Placental Vascularity as Predictors of Intrauterine Growth Restriction
The main objectives of modern antenatal care programs are to identify high risk pregnancies then to predict any possibility of adverse pregnancy outcome as early as possible.
The earliest attempts to achieve this goal were possible with the introduction of ultrasound in obstetrical practice in the 1950s. A breakthrough that enabled obstetricians to directly visualize the fetus, placenta and amniotic fluid. At first 2-dimensional (2D) imaging was employed whereby fetal biometry and placental location were detected. Later on, Doppler measurements \& 3-dimensional (3D) representation became feasible further revolutionizing this area
- Conditions
- Pre-Eclampsia
- Being tested
- ultrasound
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundProcedure or surgery
A 3D volume of the uterus will be acquired by transabdominal sonography. The sweep angle was set at 85º and the probe will be kept perpendicular to the placental plate. The placenta will be examined and the size of the volume box will be adapted in such a way that the placenta fitted into it completely. The volume will then stored for later offline analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of preeclampsia during pregnancy.
number of women developed preeclampsia
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study startOct 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349671
- Sponsor's protocol ID
- IUGRPET
- Status last verified
- Jun 2018
- First submitted
- 17 Nov 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Trimester Doppler Indices and Placental Vascularity as Predictors of Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT03349671
- Acronym / sponsor ID
- IUGRPET
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Nov 2017 (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.
The main objectives of modern antenatal care programs are to identify high risk pregnancies then to predict any possibility of adverse pregnancy outcome as early as possible.
The earliest attempts to achieve this goal were possible with the introduction of ultrasound in obstetrical practice in the 1950s. A breakthrough that enabled obstetricians to directly visualize the fetus, placenta and amniotic fluid. At first 2-dimensional (2D) imaging was employed whereby fetal biometry and placental location were detected. Later on, Doppler measurements \& 3-dimensional (3D) representation became feasible further revolutionizing this area
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who meet the eligibility criteria of the study will be invited to participate and only those who will give agreement on the informed written consent.
Key inclusion criteria (4 listed)
- Pregnant female.
- Pregnant ± 22 to 26 weeks gestation
- Singleton pregnancy.
- Consenting to participate
Key exclusion criteria (4 listed)
- Intrauterine fetal death
- Diagnosed to have Any congenital anomalies
- Symmetrical IUGR
- Established fetal compromise that necessitates delivery
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 |
|---|---|---|
| ultrasoundA 3D volume of the uterus will be acquired by transabdominal sonography. The sweep angle was set at 85º and the probe will be kept perpendicular to the placental plate. The placenta will be examined and the size of the volume box will be adapted in such a way that the placenta fitted into it completely. The volume will then stored for later offline analysis. | Procedure or surgery | – |
Primary outcome
The rate of preeclampsia during pregnancy.
Time frame: 5 months
number of women developed preeclampsia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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Preeclampsia
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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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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.
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 Pre-Eclampsia, run by Assiut 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 4 inclusion and 4 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 27 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abbas, MD (1001655790, bmr90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of preeclampsia during pregnancy. (time frame: 5 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 27 Jun 2018.