Pre EclampsiaBH4PNCT05847361
BH4 Blood Levels Variations in Pre Eclamptic Women
An observational study of Pre Eclampsia and Eclampsia, Antepartum, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre Eclampsia, Eclampsia, Antepartum, HELLP Syndrome (HELLP), Unspecified Trimester
- What is being tested?
- BH4 blood level
- How many people
- 300 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Mar 2023to 6 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Tunis maternity and neonatology center, minisetry of public health
Tunis, 1007
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pre Eclampsia, Eclampsia, Antepartum, HELLP Syndrome (HELLP), Unspecified Trimester, Acute Renal Failure, Abruptio Placentae; Complicating Pregnancy
- Being tested
- BH4 blood level
- Keywords
- BH4, Pre eclampsia, pregnancy, cesarean section
- Medical subject headings
- Pre-Eclampsia, Eclampsia, HELLP Syndrome, Acute Kidney Injury, Abruptio Placentae, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BH4 blood levelDiagnostic test
from admission to END OF PREGNANCY, a blood sample is taken.
| Study group | Role | What they receive |
|---|---|---|
| P | (P) : Preclamptic women : pregnant women diagnosed with preclampsia Receives: Diagnostic Test: BH4 blood level | |
| N | (N) : normotensive women : pregnant women without any criteria of preeclampsia Receives: Diagnostic Test: BH4 blood level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Mar 2023
- Primary completion31 Jul 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben marzouk Sofiene, University Tunis El Manar
- Investigators
- Hayen Magherbi, pr, Study chair, faculty of medecine of tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847361
- Sponsor's protocol ID
- Tunis Elmanar university
- Acronym
- BH4P
- Status last verified
- Dec 2023
- First submitted
- 6 Apr 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can bh4 Levels Predict Severity and Complications of Pre Eclampsia in Pregnant Women
- ClinicalTrials.gov ID
- NCT05847361
- Acronym / sponsor ID
- BH4P / Tunis Elmanar university
- Conditions
- Pre Eclampsia, Eclampsia, Antepartum, HELLP Syndrome (HELLP), Unspecified Trimester, Acute Renal Failure, Abruptio Placentae; Complicating Pregnancy
- Keywords
- BH4, Pre eclampsia, pregnancy, cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P | – | Diagnostic Test: BH4 blood level(P) : Preclamptic women : pregnant women diagnosed with preclampsia |
| N | – | Diagnostic Test: BH4 blood level(N) : normotensive women : pregnant women without any criteria of preeclampsia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BH4 blood levelfrom admission to END OF PREGNANCY, a blood sample is taken. | Diagnostic test | N, P |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayen Magherbi, pr study chair
faculty of medecine of tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre Eclampsia and Eclampsia, Antepartum, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.