Clinical trial NCT04944212: Prevalence of Vitamin D Deficiency in Pregnant Women and Their Fetus in North Jordan
Official title: Prevalence of Vitamin D Deficiency in Pregnant Women and Their Newborns and Their Association With Maternal and Newborns Characteristics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 396
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with singleton live fetuses who attended to labour ward

Brief summary: In Jordan, there are few data about the prevalence of hypovitaminosis D in pregnant women and their newborns and factors that affect their levels. Hence, in this study, investigators will :

1. Determine vitamin D levels among newborns born in north Jordan
2. Determine vitamin D levels among pregnant women in north Jordan
3. Study the association between maternal and infants levels of vitamin D
4. Explore the association between maternal and fetal characteristics and maternal and/or fetal vitamin D level
5. Study the effect of low fetal vitamin D on newborn anthropometry
6. Study the effect of maternal vitamin D supplement use during pregnancy in raising cord serum vitamin D levels

Detailed description: This is a cross-sectional study that will be carried out at King Abdullah University Hospital (KAUH). After being approved by the Institutional Review Board (IRB) of KAUH, written informed consents will be obtained from the newborns' mothers.

5 ml of venous blood will be obtained from pregnant women at the time of admission and 3 ml of venous blood will be obtained from the umbilical cord veins of the newborns immediately after their delivery. The quantitative measurement of 25OHD in serum will be performed using ELIZA.

Investigators will determine the means, medians and standard deviations of 25OHD levels among pregnant women and infants in Jordan. In addition, investigators will study the association between maternal and infants levels of 25OHD. Moreover, investigators will investigate the association between maternal level of vitamin D and elective maternal variables including vitamin D supplements during and before pregnancy, sun exposure, age, weight, parity, BMI, \& maternal medical problems. In addition, investigators will study the effect of low fetal vitamin D on newborn anthropometry. Finally, investigators will study the effect of maternal vitamin D supplements use during pregnancy in raising cord serum vitamin D levels

Eligibility criteria: Inclusion Criteria:

All pregnant women who attend to labour ward with singleton alive pregnancies

Exclusion Criteria:

women with multiple pregnancies or with dead fetuses

Primary outcomes:
measure: Determine maternal and fetal vitamin D level among pregnant women and their newborns in north Jordan
timeFrame: 5 minutes
Secondary outcomes:
measure: Study the association between maternal and infants levels of vitamin D. Study factors that affect maternal and fetal vitamin D level
timeFrame: 5 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
Study officials:
affiliation: Jordan University of Science and Technology
name: Rawan A Obeidat, Dr
role: PRINCIPAL_INVESTIGATOR
References: