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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Egypt2 sites
  • Ain Shams University

    Cairo

  • AinShams University

    Cairo

Other trials in Egypt

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 .

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 groups in NCT03744988
Study groupRoleWhat they receive
control groupserum androgen levels will be measured in 25 normotensive pregnant women
Receives: Diagnostic Test: serum androgen levels
mild preeclampsiaserum androgen levels will be measured in 25 mild preeclamptic patients
Receives: Diagnostic Test: serum androgen levels
severe preeclampsiaserum 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.

  1. 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.

  1. First posted19 Nov 2018
  2. Study start1 Oct 2017
  3. Primary completion30 Jun 2018
  4. Study completion30 Apr 2019 (estimated)

Resources

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
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

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.

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