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Serum Androgen Levels as a Marker for the Severity of Preeclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03744988
Recruitment Status : Active, not recruiting
First Posted : November 19, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph Adel Ibrahiem Johny, Ain Shams University

Tracking Information
First Submitted Date November 15, 2018
First Posted Date November 19, 2018
Last Update Posted Date November 20, 2018
Actual Study Start Date October 1, 2017
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03744988 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Serum Androgen Levels as a Marker for the Severity of Preeclampsia
Official Title Serum Androgen Levels as a Marker for the Severity of Preeclampsia
Brief 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
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Week
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition Severe Preeclampsia
Intervention Diagnostic Test: serum androgen levels
measurement of serum free and total testosterone
Study Groups/Cohorts
  • control group
    serum androgen levels will be measured in 25 normotensive pregnant women
    Intervention: Diagnostic Test: serum androgen levels
  • mild preeclampsia
    serum androgen levels will be measured in 25 mild preeclamptic patients
    Intervention: Diagnostic Test: serum androgen levels
  • severe preeclampsia
    serum androgen levels will be measured in 25 severe preeclamptic patients
    Intervention: Diagnostic Test: serum androgen levels
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 15, 2018)
75
Original Actual Enrollment Same as current
Estimated Study Completion Date April 30, 2019
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Pregnant women (primigravidas).
  • Age between 20 and 35 years old.
  • Live fetus.

Exclusion Criteria:

  • 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.
  • Signs or symptoms of hyper-androgenism (hirsutism, acne, oily skin, etc.).
  • Diabetes mellitus.
  • Drug use except ordinary supplementation (iron, folic acid).
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03744988
Other Study ID Numbers Joseph Adel Ibrahiem Johny
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: serum androgen levels as marker for the severity of preeclampsia
Responsible Party Joseph Adel Ibrahiem Johny, Ain Shams University
Study Sponsor Ain Shams University
Collaborators Not Provided
Investigators
Principal Investigator: Joseph A Ibrahiem, student Ain Shams University
PRS Account Ain Shams University
Verification Date November 2018