Pre-EclampsiaNCT05152550
Factors Predicting Transformation of Non Severe Pre-eclampsia Into Pre-eclampsia With Severe Features
An observational study of Pre-Eclampsia, run by Ahmed Nagy Abdul-Rahman Younis at 1 site in Egypt.
Trial summary
Preeclampsia is a multi-system progressive disorder characterized by the new onset of hypertension and proteinuria, or hypertension and significant end-organ dysfunction with or without proteinuria, in the last half of pregnancy or postpartum. 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
- Pre-Eclampsia
- What is being tested?
- Non-severe pre-eclampsia
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 30 Mar 2022
- 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: Cases diagnosed as Non-severe pre-eclampsia after exclusion of severity features
Who may be able to join
- Gestational age above 20 weeks of gestation.
- Cases diagnosed as Non-severe pre-eclampsia after exclusion of severity features which include:
- Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg.
- Symptoms of central nervous system dysfunction of new onset such as Photopsia, scotomata, cortical blindness, retinal vasospasm, and severe headache.
- Hepatic abnormality: Severe persistent right upper quadrant or Epigastric pain or serum transaminase concentration ≥2 times the upper limit of the normal range, or both.
- Thrombocytopenia: < 100,000 platelets/µL.
- Pulmonary edema.
Who cannot join
- Vesicular mole (complete or incomplete).
- Any cause of Albuminuria rather than PET such as (chronic kidney disease, type1 Diabetes mellitus.)
- Any liver disease (Acute liver diseases cause increased liver transaminases and chronic liver diseases cause decreased production of albumin and transaminases.)
- Any autoimmune disease that affects blood vessels or PLT count such as (ITP, TTP, SLE and rheumatoid arthritis.)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Maternity Hospital
Cairo, 11865
Mohamed Samy, MD
About this study
Official title: Factors Predicting Transformation of Non-severe Pre-eclampsia Into Pre-eclampsia With Severe Features
Preeclampsia is a multi-system progressive disorder characterized by the new onset of hypertension and proteinuria, or hypertension and significant end-organ dysfunction with or without proteinuria, in the last half of pregnancy or postpartum. The genesis of the disease is laid down in early pregnancy and is characterized anatomically by abnormal remodeling of the maternal spiral arteries at the placental site.
Read the detailed description
Eclampsia was firstly reported in 2200 BC in papyri of ancient Egypt. Eclampsia is originally a Greek word ´eklampsis and means "bright light". For 2000 years, eclampsia was known as a disease of convulsions in late gestation that resolves by childbirth. Scientists of late 19th century recognized the similarity in the swollen appearance of pregnant women who had seizures and explained all by the onset of glomerulonephritis with proteinuria. With the advanced noninvasive blood pressure measurement, it was observed that those women had increased blood pressure and not a long time before understanding that proteinuria and arterial hypertension occurrence before seizures. Thus, it was defined as "pre-eclampsia" that now it is a life-threatening condition for both the mother and the fetus.
Nowadays, hypertensive disorders during pregnancy, with an incidence that varies according to different measures, can exceed 10% in some population. Between multiple causes of maternal mortality and morbidity Pre-eclampsia and eclampsia are the second or third. [2]
A study made by WHO between 2003 and 2009 ranked hypertensive disorders as a cause of maternal deaths in the second grade, occurring in 14% of the cases, and in the first grade was hemorrhagic causes, responsible for 27.1%. [3] The 20th week of gestation is a period of interest as it is the landmark in the classification of hypertensive disorders because it is the time of the second wave of chorionic invasion. Thus hypertensive disorders were classified into two groups. The first one is before 20 weeks of gestation and includes essential chronic or secondary hypertension, white coat hypertension, "Masked" hypertension. The second group which appears at or after 20 weeks of gestation includes transient gestational hypertension, gestational hypertension, and pre-eclampsia.
In 2013, the American College of Obstetricians and Gynecologists (ACOG) replaced the term "severe pre-eclampsia" with the term "preeclampsia with severe features" which means systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on at least 2 occasions, at least 4 hours apart after 20 weeks of gestation in a previously normotensive patient (with or without proteinuria) and the new onset of 1 or more of the following features:
- Symptoms: Epigastric pain, hypochondrial pain, Cerebral or visual symptoms (e.g., new-onset and persistent headaches not accounted for by alternative diagnoses and not responding to usual doses of analgesics, blurred vision, flashing lights or sparks, scotomata).
- Signs: Pulmonary edema and/or generalized edema.
- Laboratory findings:
- Proteinuria ≥ 0.3 gm in a 24-hour urine specimen or protein/creatinine ratio ≥ 0.3 (mg/mg) (30 mg/m.mol) in a random urine specimen or dipstick ≥2+ if a quantitative measurement is unavailable.
- Platelet count <100,000/µL.
- Serum creatinine >1.1 mg/d L (97.2 µmol/L) or doubling of the creatinine concentration in the absence of another renal disease.
- Liver transaminases are at least twice the upper limit of the normal concentrations for the local laboratory.
In contrast to older criteria, the 2013 criteria severity features do not include proteinuria >5 g/24 hours and fetal growth restriction as features of severe disease.
So non-severe pre-eclampsia means that systolic BP from 130 to less than 160 mmHg, diastolic BP from 80 to less than 110 mmHg, and Proteinuria ≥ 0.3 gm in a 24-hour urine specimen or protein/creatinine ratio ≥ 0.3 (mg/mg) (30 mg/m.mol) in a random urine specimen or dipstick ≥2+ if a quantitative measurement is unavailable without the presence of the above-mentioned severity features.
In a woman with chronic/preexisting hypertension, criteria for superimposed preeclampsia are the new onset of proteinuria, significant end-organ dysfunction, or both after 20 weeks of gestation. For women with chronic/preexisting hypertension who have proteinuria prior to or in early pregnancy, superimposed preeclampsia is defined by worsening or resistant hypertension (especially acutely) in the last half of pregnancy or development of signs or symptoms of the severe end of the disease spectrum.
- Conditions
- Pre-Eclampsia
- Being tested
- Non-severe pre-eclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-severe pre-eclampsiaOther
Cases diagnosed as Non-severe pre-eclampsia after exclusion of severity features.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Cases diagnosed as Non-severe pre-eclampsia after exclusion of severity features Receives: Other: Non-severe pre-eclampsia |
What is being measured
The primary outcome is the main question the study is designed to answer.
severe pre-eclampsia
predicting transformation of non-severe pre-eclampsia in to pre-eclampsia with severe features
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 posted10 Dec 2021
- Study start1 May 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion30 Mar 2022 (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.
- 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
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Nagy Abdul-Rahman Younis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Nagy Abdul-Rahman Younis, Ain Shams Maternity Hospital
- Investigators
- Mohamed Samy, MD, Principal investigator, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152550
- Sponsor's protocol ID
- 122016
- Status last verified
- Dec 2021
- First submitted
- 29 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- 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 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predicting Transformation of Non-severe Pre-eclampsia Into Pre-eclampsia With Severe Features
- ClinicalTrials.gov ID
- NCT05152550
- Acronym / sponsor ID
- 122016
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Ahmed Nagy Abdul-Rahman YounisUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 10 Dec 2021 (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.
Preeclampsia is a multi-system progressive disorder characterized by the new onset of hypertension and proteinuria, or hypertension and significant end-organ dysfunction with or without proteinuria, in the last half of pregnancy or postpartum. The genesis of the disease is laid down in early pregnancy and is characterized anatomically by abnormal remodeling of the maternal spiral arteries at the placental site.
Detailed description
Eclampsia was firstly reported in 2200 BC in papyri of ancient Egypt. Eclampsia is originally a Greek word ´eklampsis and means "bright light". For 2000 years, eclampsia was known as a disease of convulsions in late gestation that resolves by childbirth. Scientists of late 19th century recognized the similarity in the swollen appearance of pregnant women who had seizures and explained all by the onset of glomerulonephritis with proteinuria. With the advanced noninvasive blood pressure measurement, it was observed that those women had increased blood pressure and not a long time before understanding that proteinuria and arterial hypertension occurrence before seizures. Thus, it was defined as "pre-eclampsia" that now it is a life-threatening condition for both the mother and the fetus.
Nowadays, hypertensive disorders during pregnancy, with an incidence that varies according to different measures, can exceed 10% in some population. Between multiple causes of maternal mortality and morbidity Pre-eclampsia and eclampsia are the second or third. [2]
A study made by WHO between 2003 and 2009 ranked hypertensive disorders as a cause of maternal deaths in the second grade, occurring in 14% of the cases, and in the first grade was hemorrhagic causes, responsible for 27.1%. [3] The 20th week of gestation is a period of interest as it is the landmark in the classification of hypertensive disorders because it is the time of the second wave of chorionic invasion. Thus hypertensive disorders were classified into two groups. The first one is before 20 weeks of gestation and includes essential chronic or secondary hypertension, white coat hypertension, "Masked" hypertension. The second group which appears at or after 20 weeks of gestation includes transient gestational hypertension, gestational hypertension, and pre-eclampsia.
In 2013, the American College of Obstetricians and Gynecologists (ACOG) replaced the term "severe pre-eclampsia" with the term "preeclampsia with severe features" which means systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on at least 2 occasions, at least 4 hours apart after 20 weeks of gestation in a previously normotensive patient (with or without proteinuria) and the new onset of 1 or more of the following features:
- Symptoms: Epigastric pain, hypochondrial pain, Cerebral or visual symptoms (e.g., new-onset and persistent headaches not accounted for by alternative diagnoses and not responding to usual doses of analgesics, blurred vision, flashing lights or sparks, scotomata).
- Signs: Pulmonary edema and/or generalized edema.
- Laboratory findings:
- Proteinuria ≥ 0.3 gm in a 24-hour urine specimen or protein/creatinine ratio ≥ 0.3 (mg/mg) (30 mg/m.mol) in a random urine specimen or dipstick ≥2+ if a quantitative measurement is unavailable.
- Platelet count <100,000/µL.
- Serum creatinine >1.1 mg/d L (97.2 µmol/L) or doubling of the creatinine concentration in the absence of another renal disease.
- Liver transaminases are at least twice the upper limit of the normal concentrations for the local laboratory.
In contrast to older criteria, the 2013 criteria severity features do not include proteinuria >5 g/24 hours and fetal growth restriction as features of severe disease.
So non-severe pre-eclampsia means that systolic BP from 130 to less than 160 mmHg, diastolic BP from 80 to less than 110 mmHg, and Proteinuria ≥ 0.3 gm in a 24-hour urine specimen or protein/creatinine ratio ≥ 0.3 (mg/mg) (30 mg/m.mol) in a random urine specimen or dipstick ≥2+ if a quantitative measurement is unavailable without the presence of the above-mentioned severity features.
In a woman with chronic/preexisting hypertension, criteria for superimposed preeclampsia are the new onset of proteinuria, significant end-organ dysfunction, or both after 20 weeks of gestation. For women with chronic/preexisting hypertension who have proteinuria prior to or in early pregnancy, superimposed preeclampsia is defined by worsening or resistant hypertension (especially acutely) in the last half of pregnancy or development of signs or symptoms of the severe end of the disease spectrum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Non-severe pre-eclampsiaCases diagnosed as Non-severe pre-eclampsia after exclusion of severity features |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cases diagnosed as Non-severe pre-eclampsia after exclusion of severity features
Key inclusion criteria (7 listed)
- Gestational age above 20 weeks of gestation.
- Cases diagnosed as Non-severe pre-eclampsia after exclusion of severity features which include:
Key exclusion criteria (4 listed)
- Vesicular mole (complete or incomplete).
- Any cause of Albuminuria rather than PET such as (chronic kidney disease, type1 Diabetes mellitus.)
- Any liver disease (Acute liver diseases cause increased liver transaminases and chronic liver diseases cause decreased production of albumin and transaminases.)
- Any autoimmune disease that affects blood vessels or PLT count such as (ITP, TTP, SLE and rheumatoid arthritis.)
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 |
|---|---|---|
| Non-severe pre-eclampsiaCases diagnosed as Non-severe pre-eclampsia after exclusion of severity features. | Other | Group A |
Primary outcome
severe pre-eclampsia
Time frame: 4 months
predicting transformation of non-severe pre-eclampsia in to pre-eclampsia with severe features
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia
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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.
Mohamed Samy, MD principal investigator
Ain Shams Maternity Hospital
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 Ahmed Nagy Abdul-Rahman Younis 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 7 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 29 Dec 2021. 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 Nagy Younis, MBBCH (+201013553910, ahmednagyyounis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severe pre-eclampsia (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 29 Dec 2021.