Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2023-03-15
2023-12-06
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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P
(P) : Preclamptic women : pregnant women diagnosed with preclampsia
BH4 blood level
from admission to END OF PREGNANCY, a blood sample is taken.
N
(N) : normotensive women : pregnant women without any criteria of preeclampsia
BH4 blood level
from admission to END OF PREGNANCY, a blood sample is taken.
Interventions
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BH4 blood level
from admission to END OF PREGNANCY, a blood sample is taken.
Eligibility Criteria
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Inclusion Criteria
* informed consent
* Pregnant
* Term of pregnancy over than 24 weeks of gestation
* Having a normal pregnancy ( for the control group)
* Being diagnosed with preeclampsia or severe preeclampsia as defined in international guidelines (for the case group)
* Women with known phenylketonuria
* Any history of ( treated or not) hypertension prior to the current pregnancy
* Any history of ( treated or not) diabetes or gestational diabetes during the current pregnancy
* Any history of renal failure or kidney injury) in the current pregnancy
* Women under long-term medications for arterial hypertension or before 24 week of the current pregnancy
18 Years
FEMALE
Yes
Sponsors
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University Tunis El Manar
OTHER
Responsible Party
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Ben marzouk Sofiene
associate professor
Principal Investigators
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Hayen Magherbi, pr
Role: STUDY_CHAIR
faculty of medecine of tunis
Locations
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Tunis maternity and neonatology center, minisetry of public health
Tunis, , Tunisia
Countries
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Other Identifiers
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Tunis Elmanar university
Identifier Type: -
Identifier Source: org_study_id