Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia
Atslēgvārdi
Abstrakts
Apraksts
The etiology and pathophysiology of preeclampsia have not been clearly established; impaired immunologic adaptation and genetic incompatibility seem to be involved in deficient trophoblastic implantation. Placental hypoxia and endothelial dysfunction may lead to preeclampsia through an exacerbated systemic inflammatory reaction. Increased placental expression and secretion of soluble fms-like tyrosine kinase 1 appear to play a central role in the pathogenesis of preeclampsia. The soluble fms-like tyrosine kinase 1 antagonizes the proangiogenic biologic activity of circulating vascular endothelial growth factor and placental growth factor, leading to a failure of nitric oxide signaling to smooth muscle The investigators will conduct a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Esomeprazole alone or with Sildenafil Citrate in preterm pregnancies complicated by preeclampsia.
Datumi
| Pēdējoreiz pārbaudīts: | 12/31/2018 |
| Pirmais iesniegtais: | 10/28/2018 |
| Paredzētā reģistrācija iesniegta: | 10/28/2018 |
| Pirmais izlikts: | 10/29/2018 |
| Pēdējais atjauninājums iesniegts: | 01/07/2019 |
| Pēdējā atjaunināšana ievietota: | 01/09/2019 |
| Faktiskais studiju sākuma datums: | 11/30/2018 |
| Paredzamais primārās pabeigšanas datums: | 11/29/2021 |
| Paredzamais pētījuma pabeigšanas datums: | 12/31/2021 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Drug: Esomeprazole with Sildenafil Citrate
Drug: Esomeprazole with Sildenafil Citrate
Drug: placebo to Esomeprazole plus placebo to Sildenafil Citrate
Drug: Placebo to Sildenafil Citrate
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Active Comparator: Esomeprazole with Sildenafil Citrate Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of Sildenafil Citrate 40mg orally every 8 hours | Drug: Esomeprazole with Sildenafil Citrate Patients will take Sildenafil Citrate 40mg every 8 hours |
| Active Comparator: Esomeprazole alone plus placebo to Sildenafil Citrate Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of placebo identical in shape and consistency withSildenafil Citrate 40mg orally every 8 hours | |
| Placebo Comparator: placebo to Esomeprazole plus placebo to Sildenafil Citrate Patients will take placebo identical in shape and consistency with esomeprazole single dose of 40 mg orally once a day plus three doses of placebo identical in shape and consistency withSildenafil Citrate 40mg orally every 8 hours | Drug: placebo to Esomeprazole plus placebo to Sildenafil Citrate Patients will take inert tablets similar in appearance, color, and consistency to esomeprazole single dose of 40 mg orally once a day |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | Female |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | Inclusion Criteria: - Pregnant women presenting at a Gestational age between 28 + 0 weeks and 32 + 0 weeks presented with preterm preeclampsia - The patient will be managed with an expectant management - Give written informed consent Exclusion Criteria: - Multiple pregnancies. - Previous hypersensitivity reaction esomeprazole or sildenafil citrate - Contraindications to the use of esomeprazole or sildenafil citrate - The patient is unable or unwilling to give consent - An established fetal compromise that necessitates delivery |
Rezultāts
Primārie rezultāti
1. Prolongation of gestation measured from the time of enrollment to the time of delivery. [3 weeks]
Sekundārie iznākuma mērījumi
1. Severe morbidity [4 weeks]
2. Side effects [4 weeks]
3. The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy [4 weeks]
