Maternal 25-hydroxy Vitamin D Level and Adverse Outcomes... | NCT03451864

Studies
Maternal 25-hydroxy Vitamin D Level and Adverse Outcomes in Near Term and Full Term Neonates

NCT03451864

Sponsor

Cairo University

Status

Completed

Last Update Posted

Mar 2, 2018Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Neonatal Outcome

Interventions

Vaginal delivery
Cesarean Section

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Feb 1, 2018Actual

Completion Date

Feb 24, 2018Actual

First Submitted Date

Feb 25, 2018

First Submission Date that Met QC Criteria

Feb 25, 2018

First Posted Date

Mar 2, 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

Feb 25, 2018

Last Update Posted Date

Mar 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study. Maternal serum 25-OHD was measured by ELISA

Detailed Description

Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study. Maternal serum 25-OHD was measured by ELISA.Maternal 25 (OH) vitamin D measurement: Blood samples for determination of serum 25 (OH) vitamin D were collected by venipuncture and processed as follows: 3 mL blood were collected into plain tubes and allowed to clot for 30 minutes, then it was centrifuged at 1500 round per minute for 15 minutes at room temperature and the serum was separated into clean, properly labeled tubes and stored at ≤ -20°C till assay. Serum 25 (OH) vitamin D level was assessed by Enzyme-Linked ImmunoSorbent Assay (ELISA) using DRG 25-OH Vitamin D (total) ELISA (DRG International, Inc., USA) according to manufacturer's instructions. Vitamin D deficiency is defined by 25(OH) D levels less than 20 ng/d

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

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Deficient Vit D		Mothers with serum 25(OH) D levels less than 20 ng/dl	Procedure: Vaginal delivery Procedure: Cesarean Section
Normal vit D		Mothers with serum 25(OH) D levels more than 20 ng/dl	Procedure: Vaginal delivery Procedure: Cesarean Section

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaginal delivery	Procedure	classic vaginal delivery	Deficient Vit D Normal vit D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neonatal intensive care unit admission	Admission of the neonate to NICU	24 hours after delivery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy women Term pregnancy

Exclusion Criteria:

any chronic illness as chronic hypertension or pregestational diabetes pregnancy-related illnesses as preeclampsia, gestational diabetes multiple pregnancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

88 full term neonates of both sexes born to 88 healthy women with a mean age was 27.0 ± 5.0 years. Forty-one (46.6%) had normal vaginal delivery and 47 (53.4%) underwent cesarean section

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Maged, MD	professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy medical school		Cairo		12111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002585	Cesarean Section

Ancestor Terms

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

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Browse Branches

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