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

Sponsor
Ain Shams Maternity Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02992145
Collaborator
(none)
80
Enrollment
1
Location
9
Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia
    Study Start Date :
    Mar 1, 2016
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Case group: This group will include forty (40) preeclampt
    Control group: This group will include forty (40) normoten

    Outcome Measures

    Primary Outcome Measures

    1. Total and free testosterone level [9 months]

      Higher in preeclamptic patients than normal pregnant ladies

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams Maternity Hospital-Faculty of Medicine- Ain Shams University Cairo Governorate Cairo Egypt 00202

    Sponsors and Collaborators

    • Ain Shams Maternity Hospital

    Investigators

    • Study Chair: Noha H Rabei, Professor of Obs&Gyn, Ain Shams Maternity Hospital
    • Study Director: Malames M Faisal, Lecturer of Obs&Gyna, Ain Shams Maternity Hospital
    • Study Director: Hoda E Abd elwahab, Fellow of medical tests, Ain Shams Hospitals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Ismail Ahmed Mohamed, Obstetrics and gynaecology resident, Ain Shams Maternity Hospital
    ClinicalTrials.gov Identifier:
    NCT02992145
    Other Study ID Numbers:
    • AinShams MH 01
    First Posted:
    Dec 14, 2016
    Last Update Posted:
    Dec 16, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Pre-Eclampsia
    Eclampsia

    Study Results

    No Results Posted as of Dec 16, 2016