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CompletedNCT02992145Updated Dec 16, 2016

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

An observational study in Pre-Eclampsia, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2016-12-16.

Sponsored by Ain Shams Maternity Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
80
Ages
20 Years to 35 Years
Sex
Female
01

Study 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).

Read the 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.
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Conditions studied

  • Pre-Eclampsia
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 80 is below the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 135 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

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).

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Case group: This group will include forty (40) preeclampt
  • Control group: This group will include forty (40) normoten
06

What researchers measure

Primary outcomes

  1. Total and free testosterone level

    Higher in preeclamptic patients than normal pregnant ladies

    Time frame: 9 months

07

Study locations

1 site
  • Ain Shams Maternity Hospital-Faculty of Medicine- Ain Shams University
    Cairo Governorate, Cairo 00202, Egypt
08

References and documents

Publications

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

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02992145
Lead sponsor
Ain Shams Maternity Hospital
Responsible party
Ahmed Ismail Ahmed Mohamed (Obstetrics and gynaecology resident, Ain Shams Maternity Hospital) — Principal investigator
First posted
Dec 14, 2016
Start date
Mar 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Dec 16, 2016

Study contacts

Noha H Rabei, Professor of Obs&Gyn
study chair · Ain Shams Maternity Hospital
Malames M Faisal, Lecturer of Obs&Gyna
study director · Ain Shams Maternity Hospital
Hoda E Abd elwahab, Fellow of medical tests
study director · Ain Shams Hospitals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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