An observational study in Pre Eclampsia, Eclampsia, Antepartum and HELLP Syndrome (HELLP), Unspecified Trimester, sponsored by University Tunis El Manar. Completed at 1 site in Tunisia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by University Tunis El Manar · Observational
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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.
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 :
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.
917 studies on the registry are indexed under Pre-Eclampsia; 244 are open to participants now.
This study's enrollment of 300 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →University Tunis El Manar is the lead sponsor of 75 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Inclusion Criteria:
Non- inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(P) : Preclamptic women : pregnant women diagnosed with preclampsia
Diagnostic Test: BH4 blood level
(N) : normotensive women : pregnant women without any criteria of preeclampsia
Diagnostic Test: BH4 blood level
from admission to END OF PREGNANCY, a blood sample is taken.
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
Time frame: 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.
Secondary outcome measures will include the associationtion between BH4 levels and gestational hypertension. gestational hypertension are defined by High Blood pressure SBP \> 160 mmHg and/or DBP \> 90 mmHg without proteinuria or any other preeclamptic criteria
Time frame: 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 preterm delivery (before 37 weeks of pregnancy)
Secondary outcome measures will include the predectivity of preterm delivery with BH4 levels
Time frame: 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.
Secondary outcome measures will include the association between BH4 levels and fetal growth restriction.
Time frame: 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
econdary outcome measures will include the association between BH4 levels and placenta abroptio
Time frame: 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 mortality
predectivity of maternal and foetal mortality by BH4 levels
Time frame: 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)
Ran from Mar 2023 to primary completion in Jul 2023, 4 months.
Of 191 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's 4 months is below that.
Counting every sponsor, half of 200 studies reached it within 30 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University Tunis El Manar