Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03744988 |
| Other study ID # |
Joseph Adel Ibrahiem Johny |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2017 |
| Est. completion date |
April 30, 2019 |
Study information
| Verified date |
November 2018 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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
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 .
