Preeclampsia
Conditions
Brief summary
This study is a randomized controlled trial with two parallel groups connected at Al-Thawra Modern General Hospital in Sana'a, Yemen. It aims to compara the effect of two different vitamin D3 supplementation regimens during pregnancy on the risk of pre-eclampsia among women with confirmed vitamin D deficiency. Pregnant women attending antenatal care and diagnosed with vitamin D deficiency will be screened for eligibility. Eligible participants will be randomly assigned to one of two intervention groups:one group receiving vitamin D3 50,000 IU every two weeks and the other group receiving vitamin D3 5,000 IU weekly,in addition to standard antenatal care. The study will include singleton pregnancies between 8\_18 weeks of gestation with serum 25-hydroxyvitamin D level below 25 ng /mL . Women with chronic conditions that may affect pregnancy outcomes or vitamin D metabolism will be excluded. Participants will be followed throughout pregnancy to assess the development of pre-eclampsia and other maternal and fetal outcomes.
Detailed description
Vitamin D deficiency during pregnancy has been associated with advers maternal and neonatal outcomes, including an increased risk of preeclampsia.However,the optimal dosage regimen of vitamin D3 supplementation in deficient pregnant women remains uncertain. This randomized controlled trial will be conducted at Al-Thawra Modern General Hospital in Sana'a, Yemen, and will include pregnant women with confirmed vitamin D deficiency in early pregnancy. Participants will be randomly assigned to one of two vitamin D3 supplementation regimens and followed throughout pregnancy. The study aims to compare the effectiveness of two different vitamin D3 dosing scheduales in reducing the incidence of preeclampsia.Maternal vitamin D status and pregnancy outcomes will be assessed as secondary measures to evaluate the overall impact of supplementation.
Interventions
DIETARY_SUPPLEMENTVitamin D3
Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.
Sponsors
Sana'a University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No additional masking beyond those specified.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention arms .Each arm will recive a different vitamin D3 supplementation regimen during pregnancy .Participants will remain in their assigned group throughout the study period until completion of follow-up Arm 1: Name: Vitamin D3 50,000 IU every 2 weeks Type: Experimental Intervention: Vitamin D3 Arm 2: Name: Vitamin D3 5,000 IU weekly Type: Experimental Intervention: Vitamin D3
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancy * Pregnant women between 8 and 18 weeks of gestation * Serum 25-hydroxyvitamin D \[25(OH)D\] level \< 25 ng/mL * Willing and able to provide written informed consent * Planning to receive ongoing antenatal care and deliver at Al-Thawra Modern General Hospital.
Exclusion criteria
* Uncontrolled chronic hypertension * Current use of vitamin D supplementation before enrollment * Severe chronic kidney disease * Pre-existing diabetes mellitus * Autoimmune or immunological disorders * Known fetal congenital anomalies * Primary hyperparathyroidism * Thyroid disease * Use of medications that affect vitamin D or calcium metabolism * Inability or unwillingness to comply with the study protocol or follow-up schedule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pre-eclampsia events | From 20 weeks of gestation until delivery | Occurance of preeclampsia during pregnancy , diagnosed according standared clinical criteria including new onset hypertention after 20weeks of gestation with proteinuria or other feature of maternal organ dysfunction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Preeclampsia | At diagnosis of preeclampsia until delivery | Description Severity of preeclampsia assessed by the need for preterm delivery, maternal intensive care unit admission, or other severe maternal complications. |
| Gestational Age at Onset of Preeclampsia | At first diagnosis of preeclampsia | Gestational age in weeks at the time of first diagnosis of preeclampsia. |
| Occurrence of Severe Maternal Complications | From enrollment until delivery | Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy |
| Incidence of Gestational Diabetes Mellitus | From enrollment until delivery] | Occurrence of gestational diabetes diagnosed according to standard clinical criteria. |
| Incidence of Gestational Hypertension | From enrollment until delivery | Occurrence of gestational hypertension diagnosed according to standard clinical criteria. |
| Maternal Mortality | From enrollment until 42 days postpartum | Death of a participant during pregnancy or within 42 days after termination of pregnancy. |
| Incidence of Low Birth Weight | At birth | Proportion of newborns with birth weight less than 2500 grams. |
| Incidence of Preterm Birth | At delivery | Delivery occurring before 37 completed weeks of gestation. |
| Neonatal Intensive Care Admission | At birth | Admission of the newborn to a neonatal intensive care unit. |
| Mean Birth Weight | At birth | Birth weight of newborns measured in grams. |
| Neonatal Mortality | From birth to 28 days of life | Death of a live-born infant during the neonatal period. |
Countries
Yemen
Contacts
CONTACTAmany Omer Taib, MBBS
PRINCIPAL_INVESTIGATORAmany Omer Taib, MBBS
Faculty of Medicine and Health Sciences, Sana'a University
Outcome results
None listed