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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992145
• Other study ID #: AinShams MH 01
• Status: Completed
• Phase: N/A
• First received: December 12, 2016
• Last updated: December 15, 2016
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital-Faculty of Medicine- Ain Shams University	Cairo Governorate	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total and free testosterone level	Higher in preeclamptic patients than normal pregnant ladies	9 months	Yes