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Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia

NCT ID: NCT02992145

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

Brief Summary

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This study aims to compare between androgens level (serum total and free testosterone) in women with preeclampsia and normal ones in the third trimester of pregnancy (28-40 weeks).

Detailed Description

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Methodology:

All women in this study will be subjected to:

* All women are candidates for this study according to inclusion and exclusion criteria.
* History taking with special emphases on last menstrual period to determine the exact Gestational age.
* A reliable date is defined as the occurrence of regular menstrual cycles (28±7 days) in patients who have not taken oral contraceptives during the three months before conception and have no irregular bleeding.
* General and abdominal examination for each patient to determine those patients matching with the inclusion criteria.
* Preeclampsia refers to the new onset of hypertension (systolic blood pressure ≥140 mmHg ,or diastolic blood pressure≥ 90 mmHg ,or both, measured on two occasions \> 6 hours apart) and either proteinuria or end organ dysfunction after 20 weeks of gestation in a previously normotensive woman.
* At Ain Shams University Hospitals, the investigator will use ELISA based test system intended for the quantitative measurement of total and free testosterone for patients of both groups.

Conditions

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Pre-Eclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case group: This group will include forty (40) preeclampt

No interventions assigned to this group

Control group: This group will include forty (40) normoten

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Pregnant women (primigravidas) at third trimester i.e. 28-40 weeks.
2. Age between 20 and 35 years old.
3. Live fetus.
4. Having no history of pregestational hypertension.
5. Having no history of diseases associated with hormone disorders (thyroid gland disorders, DM, hyperprolactinemia or polycystic ovary syndrome).
6. During their pregnancy they did not receive antihypertensive medications.
7. Nonsmoker.

Exclusion Criteria

* 1- First and second trimester pregnant women. 2- Women younger than 20 years old and older than 35 years old 3- Intrauterine fetal death. 4- History of pregestational hypertension. 5- History of hormonal disorders (thyroid gland disorders and hyperprolactinemia).

6- Smoker. 7- Polycystic ovary syndrome. 8- Signs or symptoms of hyper-androgenism (hirsutism, acne, oily skin, etc.). 9- Diabetes mellitus. 10- Drug use except ordinary supplementation (iron, folic acid).
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Ismail Ahmed Mohamed

Obstetrics and gynaecology resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noha H Rabei, Professor of Obs&Gyn

Role: STUDY_CHAIR

Ain Shams Maternity Hospital

Malames M Faisal, Lecturer of Obs&Gyna

Role: STUDY_DIRECTOR

Ain Shams Maternity Hospital

Hoda E Abd elwahab, Fellow of medical tests

Role: STUDY_DIRECTOR

Ain Shams Hospitals

Locations

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Ain Shams Maternity Hospital-Faculty of Medicine- Ain Shams University

Cairo Governorate, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

References

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https://www.ncbi.nlm.nih.gov/pubmed/12746983

Reference Type RESULT

Other Identifiers

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AinShams MH 01

Identifier Type: -

Identifier Source: org_study_id