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NCT Number: NCT02992145

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).

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Ain Shams Maternity Hospital-Faculty of Medicine- Ain Shams University

Cairo Governorate, 00202, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women (primigravidas) at third trimester i.e. 28-40 weeks.
  • Age between 20 and 35 years old.
  • Live fetus.
  • Having no history of pregestational hypertension.
  • Having no history of diseases associated with hormone disorders (thyroid gland disorders, DM, hyperprolactinemia or polycystic ovary syndrome).
  • During their pregnancy they did not receive antihypertensive medications.
  • 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).

Treatment and study plan

Primary outcomes

  1. Total and free testosterone level

    Time frame: 9 months

    Higher in preeclamptic patients than normal pregnant ladies

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2016
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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