Preterm BirthNCT03638037
Correlation Between Maternal Vitamin D Level And Preterm Birth
An observational study of Preterm Birth and Preterm Labor, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Assessment of correlation between vitamin D level and prevalence of preterm births remains limited. The exact role of vitamin D in preterm birth has not yet been clearly defined ,where some studies showed vitamin D deficiency increased the risk of preterm birth while other studies found no correlation. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Preterm Birth, Preterm Labor, Vitamin D Deficiency
- What is being tested?
- Vitamin D measurement
- How many people
- 138 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2018to Apr 2019
- 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
- Adult
Study population: Pregnant women with singelton pregnancy
Who may be able to join
- Singleton gestation.
- Maternal age: 20-35 years.
Who cannot join
- Multi fetal pregnancy.
- Anatomical or genetic defect of the fetus.
- Iatrogenic preterm delivery.
- Maternal medical disorder e.g diabetes millets (D.M).
- Antepartum hemorrhage.
- Hypertensive disorders.
Show all 11Show fewer
- Polyhydromins or oligolydromins
- Premature rupture of membranes ± Chorioamnionitis
- Incompetent cervix.
- Post IVF.
- Uterine Fibroid or malformation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University, Maternity Hospital
Cairo
Dina Mansour, Dinayahiamansour@hotmail.com
About this study
Assessment of correlation between vitamin D level and prevalence of preterm births remains limited. The exact role of vitamin D in preterm birth has not yet been clearly defined ,where some studies showed vitamin D deficiency increased the risk of preterm birth while other studies found no correlation. In this study will try to continue research on this subject.
- Conditions
- Preterm Birth, Preterm Labor, Vitamin D Deficiency
- Being tested
- Vitamin D measurement
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D measurementDiagnostic test
Maternal serum 25- hydroxyl vitamin D level
| Study group | Role | What they receive |
|---|---|---|
| Study | 69 women, delivered preterm babies (less than 37weeks). Receives: Diagnostic Test: Vitamin D measurement | |
| Control | 69 women, delivered at term (38-42 weeks) of full tem babies. Receives: Diagnostic Test: Vitamin D measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with severe vitamin D deficiency
vitamin D deficiency defined as vitamin D level <10ng/mL
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start2 Sep 2018
- Primary completionMar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Cross-sectional
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr- dina yahia mansour, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638037
- Sponsor's protocol ID
- VD0074
- Status last verified
- Oct 2018
- First submitted
- 13 Aug 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Maternal Vitamin D Level And Preterm Birth
- ClinicalTrials.gov ID
- NCT03638037
- Acronym / sponsor ID
- VD0074
- Conditions
- Preterm Birth, Preterm Labor, Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 2 Sep 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 20 Aug 2018 (actual)
- 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.
Assessment of correlation between vitamin D level and prevalence of preterm births remains limited. The exact role of vitamin D in preterm birth has not yet been clearly defined ,where some studies showed vitamin D deficiency increased the risk of preterm birth while other studies found no correlation. In this study will try to continue research on this subject.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Diagnostic Test: Vitamin D measurement69 women, delivered preterm babies (less than 37weeks). |
| Control | – | Diagnostic Test: Vitamin D measurement69 women, delivered at term (38-42 weeks) of full tem babies. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women with singelton pregnancy
Key inclusion criteria (2 listed)
- Singleton gestation.
- Maternal age: 20-35 years.
Key exclusion criteria (11 listed)
- Multi fetal pregnancy.
- Anatomical or genetic defect of the fetus.
- Iatrogenic preterm delivery.
- Maternal medical disorder e.g diabetes millets (D.M).
- Antepartum hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D measurementMaternal serum 25- hydroxyl vitamin D level | Diagnostic test | Control, Study |
Primary outcome
proportion of patients with severe vitamin D deficiency
Time frame: 3 months
vitamin D deficiency defined as vitamin D level <10ng/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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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.
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 Preterm Birth and Preterm Labor, 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Mansour (+20100657, Dinayahiamansour@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with severe vitamin D deficiency (time frame: 3 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 Oct 2018.