NCT05847361Completed
BH4 Blood Levels Variations in Pre Eclamptic Women
Can bh4 Levels Predict Severity and Complications of Pre Eclampsia in Pregnant Women
Source: ClinicalTrials.gov · Last updated 7 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 300 (actual)
- First submitted
- 6 Apr 2023
- Start date
- 15 Mar 2023
- Primary completion date
- 31 Jul 2023
- Lead sponsor
- University Tunis El Manar
- NCT number
- NCT05847361
What you commit to
- Study type: Observational
- Participants enrolled: 300
- From 15 Mar 2023 to the primary completion date, 31 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tunis maternity and neonatology center, minisetry of public health Coordinator of this site? Confirm its status | Tunis | Tunisia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.