Severe PreeclampsiaNCT03744988
Serum Androgen Levels as a Marker for the Severity of Preeclampsia
An observational study of Severe Preeclampsia, run by Ain Shams University at 2 sites in Egypt.
Trial summary
this study will be conducted to confirm the hypothesis of the previous studies and to list the high androgen levels as a precipitating factor for preeclampsia Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Severe Preeclampsia
- What is being tested?
- serum androgen levels
- How many people
- 75 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2017to 30 Apr 2019
- How long will I take part?
- 1 Week
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: patients will be divided into 3 groups 1. control group : 25 normotensive pregnant women 2. mild preeclampsia: 25 mild preeclamptic patients 3. severe preeclampsia : 25 severe preeclamptic patients
Who may be able to join
- Pregnant women (primigravidas).
- Age between 20 and 35 years old.
- Live fetus.
Who cannot join
- Women younger than 20 years old and older than 35 years old
- Intrauterine fetal death.
- History of pre-gestational hypertension.
- History of hormonal disorders (thyroid gland disorders and hyperprolactinemia).
- Smoker.
- Polycystic ovary syndrome.
Show all 9Show fewer
- Signs or symptoms of hyper-androgenism (hirsutism, acne, oily skin, etc.).
- Diabetes mellitus.
- Drug use except ordinary supplementation (iron, folic acid).
Trial locations and contacts
2 sites in 1 country.
About this study
this study will be conducted to confirm the hypothesis of the previous studies and to list the high androgen levels as a precipitating factor for preeclampsia
Read the detailed description
hypertensive disorders are one of the most important complications during pregnancy, which in combination with hemorrhage and infections make a dangerous triad, making them the major cause of maternal morbidity and mortality in 3.7-5% of all pregnancies.
Hypertensive disorders during pregnancy are classified into 4 categories, as recommended by the National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy:
- Chronic hypertension
- Preeclampsia-eclampsia
- Preeclampsia superimposed on chronic hypertension
- Gestational hypertension (transient hypertension of pregnancy or chronic hypertension identified in the latter half of pregnancy). This terminology is preferred over the older but widely used term "pregnancy-induced hypertension" (PIH) because it is more precise .
In 2008, the Society of Obstetricians and Gynecologists of Canada (SOGC) released revised guidelines that simplified the classification of hypertension in pregnancy into 2 categories, preexisting or gestational, with the option to add "with preeclampsia" to either category if additional maternal or fetal symptoms, signs, or test results support this .
Chronic hypertension is defined as blood pressure exceeding 140/90 mm Hg before pregnancy or before 20 weeks' gestation. When hypertension is first identified during a woman's pregnancy and she is at less than 20 weeks' gestation, blood pressure elevations usually represent chronic hypertension.
In contrast, new onset of elevated blood pressure readings after 20 weeks' gestation mandates the consideration and exclusion of preeclampsia .
Chronic Hypertension Chronic hypertension is a primary disorder in 90-95% of cases and may be either essential (90%) or secondary to some identifiable underlying disorder, such as renal parenchymal disease (eg, polycystic kidneys, glomerular or interstitial disease), renal vascular disease (eg, renal artery stenosis, fibro-muscular dysplasia), endocrine disorders (eg, adreno-corticosteroid or mineralocorticoid excess, pheochromocytoma, hyperthyroidism or hypothyroidism, growth hormone excess, hyperparathyroidism), coarctation of the aorta, or oral contraceptive use. About 20-25% of women with chronic hypertension develop preeclampsia during pregnancy .
Chronic hypertension occurs in up to 22% of women of childbearing age, with the prevalence varying according to age, race, and body mass index. Population-based data indicate that approximately 1% of pregnancies are complicated by chronic hypertension, 5-6% by gestational hypertension without proteinuria, and 1-2% by preeclampsia .
Differential Diagnosis
- Antiphospholipid Antibody Syndrome and Pregnancy
- Antithrombin Deficiency
- Aortic Coarctation
- Autoimmune Thyroid Disease and Pregnancy
- Cardiomyopathy, Peri-partum
- Common Pregnancy Complaints and Questions
- Cushing Syndrome
- Diabetes Mellitus and Pregnancy
- Disseminated Intravascular Coagulation
- Eclampsia
- Encephalopathy, Hypertensive
- Fetal Growth Restriction
- Gastrointestinal Disease and Pregnancy
- Glomerulonephritis, Acute
- Glomerulonephritis, Chronic
- Graves' Disease
- Hashimoto Thyroiditis
- Hematologic Disease and Pregnancy
- Hemolytic-Uremic Syndrome
- Hydatidiform Mole
- Hyper-aldosteronism, Primary
- Hyperparathyroidism
- Hypertension
- Hypertension, Malignant
- Hyperthyroidism
- Hypothyroidism
- Nephrotic Syndrome
- Normal Labor and Delivery
- Preeclampsia
- Protein C Deficiency
- Protein S Deficiency
- Pulmonary Disease and Pregnancy
- Systemic Lupus Erythematosus
- Systemic Lupus Erythematosus and Pregnancy
- Teratology and Drug Use During Pregnancy
- Thrombotic Thrombocytopenic Purpura Gestational Hypertension Gestational hypertension refers to hypertension with onset in the latter part of pregnancy (>20 weeks' gestation) without any other features of preeclampsia, and followed by normalization of the blood pressure postpartum. Of women who initially present with apparent gestational hypertension, about one third develops the syndrome of preeclampsia. As such, these patients should be observed carefully for this progression. The pathophysiology of gestational hypertension is unknown, but in the absence of features of preeclampsia, the maternal and fetal outcomes are usually normal .
Gestational hypertension may, however, be a harbinger of chronic hypertension later in life Furthermore, hypertension before pregnancy or during early pregnancy is associated with a twofold increased risk of gestational diabetes mellitus. Transient hypertension of pregnancy (ie, the development of isolated hypertension in a woman in late pregnancy without other manifestations of preeclampsia) is associated strongly with later development of chronic hypertension .
Although maternal diastolic blood pressure greater than 110 mm Hg is associated with an increased risk for placental abruption and fetal growth restriction, superimposed pre-eclamptic disorders cause most of the morbidity due to chronic hypertension during pregnancy .
Preeclampsia is defined as the new onset of hypertension and either proteinuria or end organ dysfunction after 20 weeks of gestation in a previously normotensive woman. In 2013, the American College of Obstetricians and Gynecologists removed proteinuria as an essential criterion for diagnosis of preeclampsia. They also removed massive proteinuria (5 grams/24hours) and fetal growth restriction as possible features of severe disease because massive proteinuria has a poor correlation with outcome and fetal growth restriction is managed similarly whether or not preeclampsia is diagnosed. Oliguria was also removed as a characteristic of severe disease.
Hypertension before 20 weeks' gestation is almost always due to chronic hypertension; new-onset or worsening hypertension after 20 weeks' gestation should lead to a careful evaluation for manifestations of preeclampsia .
Signs suggesting a secondary medical cause of chronic hypertension Centripetal obesity, "buffalo hump," and/or wide purple abdominal striae suggest glucocorticoid excess; other clinical signs may demonstrate hyperthyroidism, hypothyroidism, or growth hormone excess. In addition, a systolic bruit heard over the abdomen or in the flanks suggests renal artery stenosis, whereas radio femoral delay or diminished pulses in the lower versus upper extremities suggests coarctation of the aorta .
Women with chronic hypertension in pregnancy should be monitored for the development of worsening hypertension and/or the development of superimposed pre-eclampsia (the risk is approximately 25%). Laboratory investigations for pre-eclampsia should be repeated if the patient's blood pressure increases or if she develops signs or symptoms of preeclampsia .
- Conditions
- Severe Preeclampsia
- Being tested
- serum androgen levels
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum androgen levelsDiagnostic test
measurement of serum free and total testosterone
| Study group | Role | What they receive |
|---|---|---|
| control group | serum androgen levels will be measured in 25 normotensive pregnant women Receives: Diagnostic Test: serum androgen levels | |
| mild preeclampsia | serum androgen levels will be measured in 25 mild preeclamptic patients Receives: Diagnostic Test: serum androgen levels | |
| severe preeclampsia | serum androgen levels will be measured in 25 severe preeclamptic patients Receives: Diagnostic Test: serum androgen levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum androgen levels as a marker for the severity of preeclampsia
assess if serum androgen levels could be used as a marker for the severity of preclampsia
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Oct 2017
- Primary completion30 Jun 2018
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Adel Ibrahiem Johny, Ain Shams University
- Investigators
- Joseph A Ibrahiem, student, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744988
- Sponsor's protocol ID
- Joseph Adel Ibrahiem Johny
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: serum androgen levels as marker for the severity of preeclampsia
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Androgen Levels as a Marker for the Severity of Preeclampsia
- ClinicalTrials.gov ID
- NCT03744988
- Acronym / sponsor ID
- Joseph Adel Ibrahiem Johny
- Conditions
- Severe Preeclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 19 Nov 2018 (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 study will be conducted to confirm the hypothesis of the previous studies and to list the high androgen levels as a precipitating factor for preeclampsia
Detailed description
hypertensive disorders are one of the most important complications during pregnancy, which in combination with hemorrhage and infections make a dangerous triad, making them the major cause of maternal morbidity and mortality in 3.7-5% of all pregnancies.
Hypertensive disorders during pregnancy are classified into 4 categories, as recommended by the National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy:
- Chronic hypertension
- Preeclampsia-eclampsia
- Preeclampsia superimposed on chronic hypertension
- Gestational hypertension (transient hypertension of pregnancy or chronic hypertension identified in the latter half of pregnancy). This terminology is preferred over the older but widely used term "pregnancy-induced hypertension" (PIH) because it is more precise .
In 2008, the Society of Obstetricians and Gynecologists of Canada (SOGC) released revised guidelines that simplified the classification of hypertension in pregnancy into 2 categories, preexisting or gestational, with the option to add "with preeclampsia" to either category if additional maternal or fetal symptoms, signs, or test results support this .
Chronic hypertension is defined as blood pressure exceeding 140/90 mm Hg before pregnancy or before 20 weeks' gestation. When hypertension is first identified during a woman's pregnancy and she is at less than 20 weeks' gestation, blood pressure elevations usually represent chronic hypertension.
In contrast, new onset of elevated blood pressure readings after 20 weeks' gestation mandates the consideration and exclusion of preeclampsia .
Chronic Hypertension Chronic hypertension is a primary disorder in 90-95% of cases and may be either essential (90%) or secondary to some identifiable underlying disorder, such as renal parenchymal disease (eg, polycystic kidneys, glomerular or interstitial disease), renal vascular disease (eg, renal artery stenosis, fibro-muscular dysplasia), endocrine disorders (eg, adreno-corticosteroid or mineralocorticoid excess, pheochromocytoma, hyperthyroidism or hypothyroidism, growth hormone excess, hyperparathyroidism), coarctation of the aorta, or oral contraceptive use. About 20-25% of women with chronic hypertension develop preeclampsia during pregnancy .
Chronic hypertension occurs in up to 22% of women of childbearing age, with the prevalence varying according to age, race, and body mass index. Population-based data indicate that approximately 1% of pregnancies are complicated by chronic hypertension, 5-6% by gestational hypertension without proteinuria, and 1-2% by preeclampsia .
Differential Diagnosis
- Antiphospholipid Antibody Syndrome and Pregnancy
- Antithrombin Deficiency
- Aortic Coarctation
- Autoimmune Thyroid Disease and Pregnancy
- Cardiomyopathy, Peri-partum
- Common Pregnancy Complaints and Questions
- Cushing Syndrome
- Diabetes Mellitus and Pregnancy
- Disseminated Intravascular Coagulation
- Eclampsia
- Encephalopathy, Hypertensive
- Fetal Growth Restriction
- Gastrointestinal Disease and Pregnancy
- Glomerulonephritis, Acute
- Glomerulonephritis, Chronic
- Graves' Disease
- Hashimoto Thyroiditis
- Hematologic Disease and Pregnancy
- Hemolytic-Uremic Syndrome
- Hydatidiform Mole
- Hyper-aldosteronism, Primary
- Hyperparathyroidism
- Hypertension
- Hypertension, Malignant
- Hyperthyroidism
- Hypothyroidism
- Nephrotic Syndrome
- Normal Labor and Delivery
- Preeclampsia
- Protein C Deficiency
- Protein S Deficiency
- Pulmonary Disease and Pregnancy
- Systemic Lupus Erythematosus
- Systemic Lupus Erythematosus and Pregnancy
- Teratology and Drug Use During Pregnancy
- Thrombotic Thrombocytopenic Purpura Gestational Hypertension Gestational hypertension refers to hypertension with onset in the latter part of pregnancy (>20 weeks' gestation) without any other features of preeclampsia, and followed by normalization of the blood pressure postpartum. Of women who initially present with apparent gestational hypertension, about one third develops the syndrome of preeclampsia. As such, these patients should be observed carefully for this progression. The pathophysiology of gestational hypertension is unknown, but in the absence of features of preeclampsia, the maternal and fetal outcomes are usually normal .
Gestational hypertension may, however, be a harbinger of chronic hypertension later in life Furthermore, hypertension before pregnancy or during early pregnancy is associated with a twofold increased risk of gestational diabetes mellitus. Transient hypertension of pregnancy (ie, the development of isolated hypertension in a woman in late pregnancy without other manifestations of preeclampsia) is associated strongly with later development of chronic hypertension .
Although maternal diastolic blood pressure greater than 110 mm Hg is associated with an increased risk for placental abruption and fetal growth restriction, superimposed pre-eclamptic disorders cause most of the morbidity due to chronic hypertension during pregnancy .
Preeclampsia is defined as the new onset of hypertension and either proteinuria or end organ dysfunction after 20 weeks of gestation in a previously normotensive woman. In 2013, the American College of Obstetricians and Gynecologists removed proteinuria as an essential criterion for diagnosis of preeclampsia. They also removed massive proteinuria (5 grams/24hours) and fetal growth restriction as possible features of severe disease because massive proteinuria has a poor correlation with outcome and fetal growth restriction is managed similarly whether or not preeclampsia is diagnosed. Oliguria was also removed as a characteristic of severe disease.
Hypertension before 20 weeks' gestation is almost always due to chronic hypertension; new-onset or worsening hypertension after 20 weeks' gestation should lead to a careful evaluation for manifestations of preeclampsia .
Signs suggesting a secondary medical cause of chronic hypertension Centripetal obesity, "buffalo hump," and/or wide purple abdominal striae suggest glucocorticoid excess; other clinical signs may demonstrate hyperthyroidism, hypothyroidism, or growth hormone excess. In addition, a systolic bruit heard over the abdomen or in the flanks suggests renal artery stenosis, whereas radio femoral delay or diminished pulses in the lower versus upper extremities suggests coarctation of the aorta .
Women with chronic hypertension in pregnancy should be monitored for the development of worsening hypertension and/or the development of superimposed pre-eclampsia (the risk is approximately 25%). Laboratory investigations for pre-eclampsia should be repeated if the patient's blood pressure increases or if she develops signs or symptoms of preeclampsia .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Diagnostic Test: serum androgen levelsserum androgen levels will be measured in 25 normotensive pregnant women |
| mild preeclampsia | – | Diagnostic Test: serum androgen levelsserum androgen levels will be measured in 25 mild preeclamptic patients |
| severe preeclampsia | – | Diagnostic Test: serum androgen levelsserum androgen levels will be measured in 25 severe preeclamptic patients |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients will be divided into 3 groups 1. control group : 25 normotensive pregnant women 2. mild preeclampsia: 25 mild preeclamptic patients 3. severe preeclampsia : 25 severe preeclamptic patients
Key inclusion criteria (3 listed)
- Pregnant women (primigravidas).
- Age between 20 and 35 years old.
- Live fetus.
Key exclusion criteria (9 listed)
- Women younger than 20 years old and older than 35 years old
- Intrauterine fetal death.
- History of pre-gestational hypertension.
- History of hormonal disorders (thyroid gland disorders and hyperprolactinemia).
- Smoker.
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 |
|---|---|---|
| serum androgen levelsmeasurement of serum free and total testosterone | Diagnostic test | control group, mild preeclampsia, severe preeclampsia |
Primary outcome
serum androgen levels as a marker for the severity of preeclampsia
Time frame: 1 week
assess if serum androgen levels could be used as a marker for the severity of preclampsia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: Undecided. serum androgen levels as marker for the severity of preeclampsia
Related trials for Severe 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.
Joseph A Ibrahiem, student principal investigator
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Preeclampsia, run by Ain Shams University at 2 sites 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 3 inclusion and 9 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
serum androgen levels as a marker for the severity of preeclampsia (time frame: 1 week). 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 20 Nov 2018.