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

Completed

• Conditions: Pre-Eclampsia

• Registration Number: NCT02992145
• Lead Sponsor: Ain Shams Maternity Hospital

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).

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 Timeline

• Study Start: 2016-03
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-14
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total and free testosterone level	9 months	Higher in preeclamptic patients than normal pregnant ladies

Trial Locations

Locations (1)

Ain Shams Maternity Hospital-Faculty of Medicine- Ain Shams University; 🇪🇬 Cairo Governorate, Cairo, Egypt