Correlation Between Maternal Vitamin D Level And Preterm... | NCT03638037

Studies
Correlation Between Maternal Vitamin D Level And Preterm Birth

NCT03638037

Sponsor

Ain Shams Maternity Hospital

Status

Unknown status

Last Update Posted

Oct 9, 2018Actual

Enrollment

138Estimated

Phase

Not provided

Conditions

Preterm Birth
Preterm Labor
Vitamin D Deficiency

Interventions

Vitamin D measurement

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2018Actual

Primary Completion Date

Mar 2019Estimated

Completion Date

Apr 2019Estimated

First Submitted Date

Aug 13, 2018

First Submission Date that Met QC Criteria

Aug 16, 2018

First Posted Date

Aug 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2018

Last Update Posted Date

Oct 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr- dina yahia mansour, Lecturer of obstetrics and gynecology, Ain Shams Maternity HospitalPrincipal Investigator

Lead Sponsor

Ain Shams Maternity HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

138Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D measurement	Diagnostic Test	Maternal serum 25- hydroxyl vitamin D level	Control Study

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton gestation.
Maternal age: 20-35 years.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Pregnant women with singelton pregnancy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dina Mansour	Contact	+20100657		Dinayahiamansour@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University, Maternity Hospital	Recruiting	Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D007752	Obstetric Labor, Premature
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided