NCT02992145

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

9 months

First QC Date

December 12, 2016

Last Update Submit

December 15, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total and free testosterone level

    Higher in preeclamptic patients than normal pregnant ladies

    9 months

Study Arms (2)

Case group: This group will include forty (40) preeclampt

Control group: This group will include forty (40) normoten

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo Governorate, Cairo Governorate, 00202, Egypt

Location

Related Publications (1)

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

    RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Noha H Rabei, Professor of Obs&Gyn

    Ain Shams Maternity Hospital

    STUDY CHAIR
  • Malames M Faisal, Lecturer of Obs&Gyna

    Ain Shams Maternity Hospital

    STUDY DIRECTOR
  • Hoda E Abd elwahab, Fellow of medical tests

    Ain Shams Hospitals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrics and gynaecology resident

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 14, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations