NCT03744988

Brief Summary

this study will be conducted to confirm the hypothesis of the previous studies and to list the high androgen levels as a precipitating factor for preeclampsia

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

November 15, 2018

Last Update Submit

November 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • serum androgen levels as a marker for the severity of preeclampsia

    assess if serum androgen levels could be used as a marker for the severity of preclampsia

    1 week

Study Arms (3)

control group

serum androgen levels will be measured in 25 normotensive pregnant women

Diagnostic Test: serum androgen levels

mild preeclampsia

serum androgen levels will be measured in 25 mild preeclamptic patients

Diagnostic Test: serum androgen levels

severe preeclampsia

serum androgen levels will be measured in 25 severe preeclamptic patients

Diagnostic Test: serum androgen levels

Interventions

serum androgen levelsDIAGNOSTIC_TEST

measurement of serum free and total testosterone

control groupmild preeclampsiasevere preeclampsia

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients will be divided into 3 groups 1. control group : 25 normotensive pregnant women 2. mild preeclampsia: 25 mild preeclamptic patients 3. severe preeclampsia : 25 severe preeclamptic patients

You may qualify if:

  • Pregnant women (primigravidas).
  • Age between 20 and 35 years old.
  • Live fetus.

You may not qualify if:

  • Women younger than 20 years old and older than 35 years old
  • Intrauterine fetal death.
  • History of pre-gestational hypertension.
  • History of hormonal disorders (thyroid gland disorders and hyperprolactinemia).
  • Smoker.
  • Polycystic ovary syndrome.
  • Signs or symptoms of hyper-androgenism (hirsutism, acne, oily skin, etc.).
  • Diabetes mellitus.
  • Drug use except ordinary supplementation (iron, folic acid).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain Shams University

Cairo, Egypt

Location

AinShams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Joseph A Ibrahiem, student

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 19, 2018

Study Start

October 1, 2017

Primary Completion

June 30, 2018

Study Completion

April 30, 2019

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations