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

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).

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Cairo Governorate, Cairo, Egypt, 00202
      • Ain Shams Maternity Hospital-Faculty of Medicine- Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Study Site:

Ain Shams University Maternity Hospital

Study Design:

This study is a case control study.

Study Population:

Patients will be divided into two groups:

Case group:

This group will include forty (40) preeclamptic patients at the third trimester (28-40 weeks) admitted at Ain Shams University Maternity Hospital.

Control group:

This group will include forty (40) normotensive pregnant women at term admitted at Ain Shams University Maternity Hospital.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Case group: This group will include forty (40) preeclampt
Control group: This group will include forty (40) normoten

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total and free testosterone level	Higher in preeclamptic patients than normal pregnant ladies	9 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: December 15, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: AinShams MH 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED