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

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ClinicalTrials.gov Identifier: NCT03451864
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Tracking Information
First Submitted Date February 25, 2018
First Posted Date March 2, 2018
Last Update Posted Date March 2, 2018
Actual Study Start Date September 1, 2016
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2018)
Neonatal intensive care unit admission [ Time Frame: 24 hours after delivery ]
Admission of the neonate to NICU
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Maternal 25-hydroxy Vitamin D Level and Adverse Outcomes in Near Term and Full Term Neonates
Official Title Maternal 25-hydroxy Vitamin D Level and Adverse Outcomes in Near Term and Full Term Neonates
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition Neonatal Outcome
Intervention
  • Procedure: Vaginal delivery
    classic vaginal delivery
  • Procedure: Cesarean Section
    routine lower segment cesarean scetion
Study Groups/Cohorts
  • Deficient Vit D
    Mothers with serum 25(OH) D levels less than 20 ng/dl
    Interventions:
    • Procedure: Vaginal delivery
    • Procedure: Cesarean Section
  • Normal vit D
    Mothers with serum 25(OH) D levels more than 20 ng/dl
    Interventions:
    • Procedure: Vaginal delivery
    • Procedure: Cesarean Section
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 25, 2018)
88
Original Actual Enrollment Same as current
Actual Study Completion Date February 24, 2018
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03451864
Other Study ID Numbers 29
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ahmed Maged, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators
Principal Investigator: Ahmed Maged, MD professor
PRS Account Cairo University
Verification Date February 2018