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Trial record 71 of 148 for:    severe preeclampsia AND hypertensive disorders

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

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

Condition or disease Intervention/treatment
Severe Preeclampsia Diagnostic Test: serum androgen levels

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Serum Androgen Levels as a Marker for the Severity of Preeclampsia
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control group
serum androgen levels will be measured in 25 normotensive pregnant women
Diagnostic Test: serum androgen levels
measurement of serum free and total testosterone

mild preeclampsia
serum androgen levels will be measured in 25 mild preeclamptic patients
Diagnostic Test: serum androgen levels
measurement of serum free and total testosterone

severe preeclampsia
serum androgen levels will be measured in 25 severe preeclamptic patients
Diagnostic Test: serum androgen levels
measurement of serum free and total testosterone




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744988


Locations
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Egypt
Ain Shams University
Cairo, Egypt
AinShams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Joseph A Ibrahiem, student Ain Shams University

Additional Information:

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Responsible Party: Joseph Adel Ibrahiem Johny, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03744988     History of Changes
Other Study ID Numbers: Joseph Adel Ibrahiem Johny
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: serum androgen levels as marker for the severity of preeclampsia

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Ascorbic Acid
Methyltestosterone
Androgens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents