BH4 Blood Levels Variations in Pre Eclamptic Women

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

The investigators will conduct a monocentric , prospective, observational study, including 300 pregnant women (150 normotensive and 150 preeclamptic). The participants will be divided into 2 equal groups : - Group P : Preclampsia - Group N : Normotensive After written and informed consent are obtained, a standard battery of blood tests including serum BH4 will be runned for the eligible patients at any moment from the admission to the end of the pregnancy. Baseline data will be collected at enrollment, including demographic and medical history information, blood pressure, proteinuria, and blood samples for BH4 and other biomarker measurements. Follow-up data will be collected at delivery, including blood pressure, proteinuria, and fetal growth measurements, as well as maternal and neonatal outcomes; After collecting all groups, blood samples will be analysed for BH4. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05847361
Study type	Observational
Source	University Tunis El Manar
Contact
Status	Completed
Phase
Start date	March 15, 2023
Completion date	December 6, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

BH4 Blood Levels Variations in Pre Eclamptic Women — BH4P

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms