BH4 Blood Levels Variations in Pre Eclamptic Women

NCT05847361 | Completed

• 1 other identifier: Tunis Elmanar university
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre Eclampsia; Eclampsia, Antepartum; HELLP Syndrome (HELLP), Unspecified Trimester; Acute Renal Failure; Abruptio Placentae; Complicating Pregnancy

Keywords

BH4; Pre eclampsia; pregnancy; cesarean section

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Other Outcomes (4)

• 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)

Study Arms (2)

P

(P) : Preclamptic women : pregnant women diagnosed with preclampsia

Diagnostic Test: BH4 blood level

N

(N) : normotensive women : pregnant women without any criteria of preeclampsia

Diagnostic Test: BH4 blood level

Interventions

BH4 blood level DIAGNOSTIC_TEST

from admission to END OF PREGNANCY, a blood sample is taken.

N; P

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Tunis maternity and neonatology center, minisetry of public health

Tunis, 1007, Tunisia

Location

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia; HELLP Syndrome; Acute Kidney Injury; Abruptio Placentae; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Obstetric Labor Complications; Placenta Diseases

Study Officials

• Hayen Magherbi, pr

  faculty of medecine of tunis

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 6, 2023
• Study Start: March 15, 2023
• Primary Completion: July 31, 2023
• Study Completion: December 6, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

TU (1)