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

Neonatal Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451864
• Other study ID #: 29
• Status: Completed
• Phase: N/A
• First received: February 25, 2018
• Last updated: February 25, 2018
• Start date: September 1, 2016
• Est. completion date: February 24, 2018

Study information

• Verified date: February 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 24, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Outcome

Intervention

Procedure:
• Vaginal delivery
classic vaginal delivery
• Cesarean Section
routine lower segment cesarean scetion

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal intensive care unit admission	Admission of the neonate to NICU	24 hours after delivery