BH4 Blood Levels Variations in Pre Eclamptic Women (BH4P)

December 6, 2023 updated by: Ben marzouk Sofiene, University Tunis El Manar

Can bh4 Levels Predict Severity and Complications of Pre Eclampsia in Pregnant Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia, 1007
        • Tunis maternity and neonatology center, minisetry of public health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
P
(P) : Preclamptic women : pregnant women diagnosed with preclampsia
Diagnostic test: 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
Diagnostic test: BH4 blood level
from admission to END OF PREGNANCY, a blood sample is taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the association between BH4 blood level (ng/mL) and severity of preeclampsia (biological and clinical 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 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
the association between BH4 blood level (ng/mL) and gestational hypertension.
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)

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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
the association between BH4 blood level (ng/mL) and preterm delivery (before 37 weeks of pregnancy)
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)
Secondary outcome measures will include the predectivity of preterm delivery with BH4 levels
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.
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)
Secondary outcome measures will include the association between BH4 levels 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
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)
econdary outcome measures will include the association between BH4 levels 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)
the association between BH4 blood level (ng/mL) and mortality
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)
predectivity of maternal and foetal mortality by BH4 levels
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Tunis El Manar

Investigators

  • Study Chair: Hayen Magherbi, pr, Faculty of Medecine of Tunis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

December 6, 2023

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tunis Elmanar university

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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