Clinical trial NCT05847361: BH4 Blood Levels Variations in Pre Eclamptic Women
Official title: Can bh4 Levels Predict Severity and Complications of Pre Eclampsia in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre Eclampsia
Eclampsia, Antepartum
HELLP Syndrome (HELLP), Unspecified Trimester
Acute Renal Failure
Abruptio Placentae; Complicating Pregnancy
Keywords: BH4
Pre eclampsia
pregnancy
cesarean section
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Women aged over 18 YEARS
* 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)

Non- inclusion Criteria:

* 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

Primary outcomes:
measure: the association between BH4 blood level (ng/mL) and severity of preeclampsia (biological and clinical criteria)
timeFrame: 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)
Secondary outcomes:
measure: the association between BH4 blood level (ng/mL) and gestational hypertension.
timeFrame: 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)
Other outcomes:
measure: the association between BH4 blood level (ng/mL) and preterm delivery (before 37 weeks of pregnancy)
timeFrame: 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)
measure: the association between BH4 blood level (ng/mL) and fetal growth restriction.
timeFrame: 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)
measure: the association between BH4 blood level (ng/mL) and placenta abroptio
timeFrame: 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)
measure: the association between BH4 blood level (ng/mL) and mortality
timeFrame: 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)
Locations:
city: Tunis
country: Tunisia
facility: Tunis maternity and neonatology center, minisetry of public health
Study officials:
affiliation: faculty of medecine of tunis
name: Hayen Magherbi, pr
role: STUDY_CHAIR
References: