Clinical trial NCT02992145: Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia
Official title: Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Total and free testosterone level
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo Governorate
country: Egypt
facility: Ain Shams Maternity Hospital-Faculty of Medicine- Ain Shams University
state: Cairo
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Noha H Rabei, Professor of Obs&Gyn
role: STUDY_CHAIR
affiliation: Ain Shams Maternity Hospital
name: Malames M Faisal, Lecturer of Obs&Gyna
role: STUDY_DIRECTOR
affiliation: Ain Shams Hospitals
name: Hoda E Abd elwahab, Fellow of medical tests
role: STUDY_DIRECTOR
References:
citation: https://www.ncbi.nlm.nih.gov/pubmed/12746983