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

Completed

• Conditions: Neonatal Outcome
• Interventions: Procedure: Vaginal delivery; Procedure: Cesarean Section

• Registration Number: NCT03451864
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2016-09-01
• Status Verified: 2018-02
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-24
• Study First Submitted: 2018-02-25
• Study First Submitted QC: 2018-02-25
• Last Update Submitted: 2018-02-25
• Study First Posted: 2018-03-02
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• Healthy women Term pregnancy

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Neonatal intensive care unit admission	24 hours after delivery	Admission of the neonate to NICU

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt