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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment
Neonatal Outcome Procedure: Vaginal delivery Procedure: Cesarean Section

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

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Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal 25-hydroxy Vitamin D Level and Adverse Outcomes in Near Term and Full Term Neonates
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
Deficient Vit D
Mothers with serum 25(OH) D levels less than 20 ng/dl
Procedure: Vaginal delivery
classic vaginal delivery

Procedure: Cesarean Section
routine lower segment cesarean scetion

Normal vit D
Mothers with serum 25(OH) D levels more than 20 ng/dl
Procedure: Vaginal delivery
classic vaginal delivery

Procedure: Cesarean Section
routine lower segment cesarean scetion




Primary Outcome Measures :
  1. Neonatal intensive care unit admission [ Time Frame: 24 hours after delivery ]
    Admission of the neonate to NICU



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451864


Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12111
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD professor
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Responsible Party: Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03451864    
Other Study ID Numbers: 29
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No