Pre-EclampsiaNCT02992145
Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia
An observational study of Pre-Eclampsia, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Pre-Eclampsia
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams Maternity Hospital-Faculty of Medicine- Ain Shams University
Cairo Governorate, Cairo Governorate, 00202
About this study
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.
- Conditions
- Pre-Eclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group: This group will include forty (40) preeclampt | Not described | |
| Control group: This group will include forty (40) normoten | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and free testosterone level
Higher in preeclamptic patients than normal pregnant ladies
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ismail Ahmed Mohamed, Ain Shams Maternity Hospital
- Investigators
- Noha H Rabei, Professor of Obs&Gyn, Study chair, Ain Shams Maternity HospitalMalames M Faisal, Lecturer of Obs&Gyna, Study director, Ain Shams Maternity HospitalHoda E Abd elwahab, Fellow of medical tests, Study director, Ain Shams Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992145
- Sponsor's protocol ID
- AinShams MH 01
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
https://www.ncbi.nlm.nih.gov/pubmed/12746983
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia
- ClinicalTrials.gov ID
- NCT02992145
- Acronym / sponsor ID
- AinShams MH 01
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group: This group will include forty (40) preeclampt | – | – |
| Control group: This group will include forty (40) normoten | – | – |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total and free testosterone level
Time frame: 9 months
Higher in preeclamptic patients than normal pregnant ladies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Results publicationhttps://www.ncbi.nlm.nih.gov/pubmed/12746983
- Individual participant dataSharing planned: Undecided
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total and free testosterone level (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02992145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.