Can nitric oxide donors treatment improve pregnancy outcome in patients with antiphospholipid syndrome?

Prospective, randomized, controlled trial comparing low dose aspirin plus low molecular weight heparin and low dose aspirin plus nitric oxide donors as regards pregnancy outcome in patients with history of obstetric morbidity due to antiphospholipid syndrome.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000586617

Enrollment

Registered

2014-06-02

Start date

2009-01-01

Completion date

2013-12-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Adverse pregnancy outcome as recurrent abortion, premature labor and severe preeclampsia due to antiphospholipid syndrome is attributed to placental thrombosis; So, the traditional treatment is oral low dose aspirin plus subcutaneous low molecular weight heparin. Results in most studies are unsatisfactory because other pathologies do exist. Impaired synthesis of endogenous nitric oxide has been recently put forward. In this study we compare the traditional treatment with low dose aspirin plus the nitric oxide donors isosorbid mononitrate applied vaginally with the aim of improving pregnancy outcome especially the live birth rate

Interventions

Prospective, randomized controlled trial. Two groups of pregnant women each 17 cases with a history of recurrent abortion or premature labor due to antiphospholipid syndrome were randomized to a control group treated once daily with oral low dose aspirin 81 mg plus subcutaneous low molecular weight heparin 40 mg, and a study group treated once daily with low dose aspirin 81 mg plus isosorbid mononitrate 20 mg tablet applied vaginally. Treatment started once pregnancy was confirmed by B-hCG and u

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

20 Years to 30 Years

Healthy volunteers

Inclusion criteria

Patients with recurrent abortion or premature labor with preclampsia due to antiphospholipid syndrome

Exclusion criteria

Recurrent abortion or premature labor due to causes other than antiphospholipid syndrome as uterine anomalies, cervical incompetence and chronic diseases

Outcome results