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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03638037
Other study ID # VD0074
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2, 2018
Est. completion date April 2019

Study information

Verified date October 2018
Source Ain Shams Maternity Hospital
Contact Dina Mansour
Phone +20100657
Email Dinayahiamansour@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. In this study will try to continue research on this subject.


Recruitment information / eligibility

Status Recruiting
Enrollment 138
Est. completion date April 2019
Est. primary completion date March 2019
Accepts healthy volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Vitamin D measurement
Maternal serum 25- hydroxyl vitamin D level

Locations

Country Name City State
Egypt Ain Shams University, Maternity Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary proportion of patients with severe vitamin D deficiency vitamin D deficiency defined as vitamin D level <10ng/mL 3 months
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