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

NCT ID: NCT03451864

Last Updated: 2018-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-02-24

Brief Summary

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

Detailed Description

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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

Conditions

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Neonatal Outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Deficient Vit D

Mothers with serum 25(OH) D levels less than 20 ng/dl

Vaginal delivery

Intervention Type PROCEDURE

classic vaginal delivery

Cesarean Section

Intervention Type PROCEDURE

routine lower segment cesarean scetion

Normal vit D

Mothers with serum 25(OH) D levels more than 20 ng/dl

Vaginal delivery

Intervention Type PROCEDURE

classic vaginal delivery

Cesarean Section

Intervention Type PROCEDURE

routine lower segment cesarean scetion

Interventions

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Vaginal delivery

classic vaginal delivery

Intervention Type PROCEDURE

Cesarean Section

routine lower segment cesarean scetion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maged

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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29

Identifier Type: -

Identifier Source: org_study_id

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