NCT03638037

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

September 2, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

August 13, 2018

Last Update Submit

October 5, 2018

Conditions

Preterm BirthPreterm LaborVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • proportion of patients with severe vitamin D deficiency

    vitamin D deficiency defined as vitamin D level \<10ng/mL

    3 months

Study Arms (2)

Study

69 women, delivered preterm babies (less than 37weeks).

Diagnostic Test: Vitamin D measurement

Control

69 women, delivered at term (38-42 weeks) of full tem babies.

Diagnostic Test: Vitamin D measurement

Interventions

Vitamin D measurementDIAGNOSTIC_TEST

Maternal serum 25- hydroxyl vitamin D level

ControlStudy

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women with singelton pregnancy

You may qualify if:

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

You may not qualify if:

  • 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.
  • Polyhydromins or oligolydromins
  • Premature rupture of membranes ± Chorioamnionitis
  • Incompetent cervix.
  • Post IVF.
  • Uterine Fibroid or malformation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University, Maternity Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Premature BirthObstetric Labor, PrematureVitamin D Deficiency

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Dina Mansour

CONTACT

+20100657Dinayahiamansour@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 20, 2018

Study Start

September 2, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

EG(1)