Pre-EclampsiaNCT02677233
Association Between Vitamin D Deficiency and Preeclampsia: A Case Control Study
An observational study of Pre-Eclampsia, run by Ain Shams Maternity Hospital.
Trial summary
To find out if lower levels of vitamin D is more prevalent in preeclamptic women Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pre-Eclampsia
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jan 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will be carried out on 90 pregnant women recruited at pre labour room at Ain Shams University Maternity Hospital. They will be divided into preeclamptic group and non preeclamptic group, 45 cases in each one
Who may be able to join
- Parity: primigravida.
- Age: 18 - 35 years.
- Singleton pregnancy.
- Gestational age: 36-40 weeks.
- No past history of any medical disorder and with no other medical complications during pregnancy
Who cannot join
- Women with preexisting medical conditions like rheumatoid arthritis, thyroid, hepatic or renal failure, metabolic bone disease, diabetes mellitus, malabsorption and lupus.
- History of intake of medications influencing bone, vitamin D or calcium metabolism e.g. antiepileptic, theophylline, antitubercular drugs in the last 6 months.
- Women with multiple pregnancy.
- Women with congenital fetal malformation.
- Women with known thrombophilia
About this study
To find out if lower levels of vitamin D is more prevalent in preeclamptic women
- 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 |
|---|---|---|
| preeclamptic group | 1. Blood pressure: greater than or equal to 140 mmHg systolic or greater than or equal to 90 mmHg diastolic on two occasions at least 4 hours apart after 20 weeks of gestation (Roberts et al., 2013). 2. Proteinuria: protein/creatinine ratio greater than or equal to 0.3 3. In the absence of proteinuria, a new-onset hypertension with new onset of the following: * thrombocytopenia: platelet count less than 100.000/microliter * renal insufficiency: serum creatinine greater than 1.1 mg/dl * impaired liver function: elevated concentration of liver transaminases * pulmonary edema * cerebral or visual symptoms * Severe right upper quadrant or epigastric pain unresponsive to medication. | |
| non preeclamptic group | All are normotensive with blood pressure <140/90 with no proteinuria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D level in preeclamptic and non preeclamptic women
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah sayed, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677233
- Sponsor's protocol ID
- vid-20
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Vitamin D Deficiency and Preeclampsia: A Case Control Study
- ClinicalTrials.gov ID
- NCT02677233
- Acronym / sponsor ID
- vid-20
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Feb 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.
To find out if lower levels of vitamin D is more prevalent in preeclamptic women
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preeclamptic group | – | –1. Blood pressure: greater than or equal to 140 mmHg systolic or greater than or equal to 90 mmHg diastolic on two occasions at least 4 hours apart after 20 weeks of gestation (Roberts et al., 2013). 2. Proteinuria: protein/creatinine ratio greater than or equal to 0.3 3. In the absence of proteinuria, a new-onset hypertension with new onset of the following: * thrombocytopenia: platelet count less than 100.000/microliter * renal insufficiency: serum creatinine greater than 1.1 mg/dl * impaired liver function: elevated concentration of liver transaminases * pulmonary edema * cerebral or visual symptoms * Severe right upper quadrant or epigastric pain unresponsive to medication. |
| non preeclamptic group | – | –All are normotensive with blood pressure <140/90 with no proteinuria. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will be carried out on 90 pregnant women recruited at pre labour room at Ain Shams University Maternity Hospital. They will be divided into preeclamptic group and non preeclamptic group, 45 cases in each one
Key inclusion criteria (5 listed)
- Parity: primigravida.
- Age: 18 - 35 years.
- Singleton pregnancy.
- Gestational age: 36-40 weeks.
- No past history of any medical disorder and with no other medical complications during pregnancy
Key exclusion criteria (5 listed)
- Women with preexisting medical conditions like rheumatoid arthritis, thyroid, hepatic or renal failure, metabolic bone disease, diabetes mellitus, malabsorption and lupus.
- History of intake of medications influencing bone, vitamin D or calcium metabolism e.g. antiepileptic, theophylline, antitubercular drugs in the last 6 months.
- Women with multiple pregnancy.
- Women with congenital fetal malformation.
- Women with known thrombophilia
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
vitamin D level in preeclamptic and non preeclamptic women
Time frame: six months
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 9 Feb 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Ain Shams Maternity Hospital.
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 5 inclusion and 5 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 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
vitamin D level in preeclamptic and non preeclamptic women (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2016; AzTrials last refreshed its copy on 2 Nov 2026.