NCT05847361|Completed
BH4 Blood Levels Variations in Pre Eclamptic Women
BH4P
Can bh4 Levels Predict Severity and Complications of Pre Eclampsia in Pregnant Women
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BH4P
Can bh4 Levels Predict Severity and Complications of Pre Eclampsia in Pregnant Women
Sponsor study identifier
observational
300
1 country
1
Study Start
March 15, 2023
Actual (reported)Primary Completion
July 31, 2023
Actual (reported)Study Completion
December 6, 2023
Actual (reported)tetrahydrobiopterin (BH4) is degraded by several enzymes, including BH4 oxidase and peroxidases. Several factors can affect its synthesis and degradation. BH4 deficiency or depletion and genetic variations in the genes involved in BH4 metabolism have been associated with hypertension, suggesting that BH4 may play a role in the pathogenesis of hypertension. The maternity center of Tunis ( CMNT ) is a level 3 maternity center, supporting over 12 000 births yearly, where the caesarean section's rate is very high, close to 45% of deliveries. Early detection of these patients can help control maternal and neonatal safety outcomes. we can avoid complications such as severe preeclampsia, HELLP syndrom and eclampsia for the mother, and preterm delievery and fetal growth restriction for the new born. in the literature, studies have reported a decrease in BH4 levels in pregnant women compared to non-pregnant women and others showed that its deficiency or depletion has been associated with hypertension. Moreover, tetrahydrobiopterin administration has been studied as a potential treatment for preeclampsia but the optimal dose has not yet been determined, and further studies are needed to determine the appropriate dose, timing, and duration of BH4 supplementation in this context. Thus, BH4 blood levels as a mean of screening, could enrich our diagnostic arsenal. The purpose of our study is to compare BH4 levels between preeclamptic and normotensive women.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 6, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 15, 2023
Actual (reported)April 6, 2023
Actual (reported)May 6, 2023
Actual (reported)July 31, 2023
Actual (reported)December 6, 2023
Actual (reported)the association between BH4 blood level (ng/mL) and severity of preeclampsia (biological and clinical criteria)
The primary outcome measure will be the association between BH4 levels and the severity of preeclampsia, including maternal and fetal complications Preeclampsia is defined by : Systolic blood pressure (SBP) higher than 140 mmHg or/and diastolic blood pressure (DBP)higher than 90 mmHg whith proteinuria higher than 0.3 g/24 h Its sevrity is defined by at least one of those criteria: * SBP \> 160 mmHg and/or DBP \>110 mmHg * proteinuria \> 3g/24h * creatini level \> 90 µmol/ l * oliguria \< 500 ml /24 hours or \< 25 ml/ h * thrombocytopenia \< 100.000/mm3 * Cytolysis \> two times the normal value * neurosensory signs * chest pain , acute lung edema, dyspnea
From date of first admission until the date of foetal extraction, starting from 20 weeks of pregnancy to it's end (Maximal time frame : 22 weeks)
the association between BH4 blood level (ng/mL) and gestational hypertension.
From date of first admission until the date of foetal extraction, starting from 20 weeks of pregnancy to it's end (Maximal time frame : 22 weeks)
(P) : Preclamptic women : pregnant women diagnosed with preclampsia
(N) : normotensive women : pregnant women without any criteria of preeclampsia
from admission to END OF PREGNANCY, a blood sample is taken.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
300 parturients free from any exclusion criteria , devided equally into 2 groups : Group P : Preclamptic women : pregnant women in which the diagnosis of preclampsia have been sustaiend Group N : Normotensive women : pregnant women without any criteria of preeclampsia
Tunis maternity and neonatology center, minisetry of public health
Tunis, 1007, Tunisia
Hayen Magherbi, pr
faculty of medecine of tunis
300 participants (actual enrollment reported by the registry).
First Submitted
April 6, 2023
First Posted
May 6, 2023
Study Start
March 15, 2023
Actual (reported)Maternal Serum Stathmin-1 Levels in Preeclampsia
the association between BH4 blood level (ng/mL) and preterm delivery (before 37 weeks of pregnancy)
From date of first admission until the date of foetal extraction, starting from 20 weeks of pregnancy to it's end (Maximal time frame : 22 weeks)
the association between BH4 blood level (ng/mL) and fetal growth restriction.
From date of first admission until the date of foetal extraction, starting from 20 weeks of pregnancy to it's end (Maximal time frame : 22 weeks)
the association between BH4 blood level (ng/mL) and placenta abroptio
From date of first admission until the date of foetal extraction, starting from 20 weeks of pregnancy to it's end (Maximal time frame : 22 weeks)
Contact the study team to confirm eligibility.
Primary Completion
July 31, 2023
Actual (reported)Study Completion
December 6, 2023
Actual (reported)Last Updated
December 7, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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