Correlation Between Maternal Vitamin D Level And Preterm Birth

October 5, 2018 updated by: Dr- dina yahia mansour, Ain Shams Maternity Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women with singelton pregnancy

Description

Inclusion Criteria:

  • Singleton gestation.
  • Maternal age: 20-35 years.

Exclusion Criteria:

  1. Multi fetal pregnancy.
  2. Anatomical or genetic defect of the fetus.
  3. Iatrogenic preterm delivery.
  4. Maternal medical disorder e.g diabetes millets (D.M).
  5. Antepartum hemorrhage.
  6. Hypertensive disorders.
  7. Polyhydromins or oligolydromins
  8. Premature rupture of membranes ± Chorioamnionitis
  9. Incompetent cervix.
  10. Post IVF.
  11. Uterine Fibroid or malformation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study
69 women, delivered preterm babies (less than 37weeks).
Diagnostic test: Vitamin D measurement
Maternal serum 25- hydroxyl vitamin D level
Control
69 women, delivered at term (38-42 weeks) of full tem babies.
Diagnostic test: Vitamin D measurement
Maternal serum 25- hydroxyl vitamin D level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of patients with severe vitamin D deficiency
Time Frame: 3 months
vitamin D deficiency defined as vitamin D level <10ng/mL
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VD0074

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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