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nitric oxide donors drugs for treatment of recurrent abortion due to primary antiphospholipid syndrome

Prospective, randomized, controlled pilot study of aspirin plus nitric oxide donors treatment of recurrent abortion due to primary antiphospholipid syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001085763
Enrollment
34
Registered
2013-09-27
Start date
2013-09-24
Completion date
Unknown
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

Antiphospholipid syndrome (an autoimmune disease) is important cause for recurrent abortion (Three or more spontaneous successive abortion). Low dose aspirin and low molecular weight heparin are used for treatment on the assumption that the disease leads to placental thrombosis and fetal demise but results of treatment are unsatisfactory. Recently, abnormal endogenous nitric oxide synthesis was alleged to play a role.This study was performed to know if treatment with nitric oxide donors (drugs the release nitric oxide in the body) will improve pregnancy outcome and the full term live birth rate

Interventions

Prospective, randomized, controlled pilot study of aspirin plus nitric oxide donors treatment of recurrent abortion due to primary antiphospholipid syndrome Two groups of pregnant with history of recurrent abortion due to primary antiphospholipid syndrome. The control group was treated with acetyl salicylic acid 81 mg oral tablets (low dose aspirin) alone once daily and the study group was treated with low dose aspirin 81 mg oral tablets plus 20 mg isosorbid mononitrate tablets applied vagina

Prospective, randomized, controlled pilot study of aspirin plus nitric oxide donors treatment of recurrent abortion due to primary antiphospholipid syndrome Two groups of pregnant with history of recurrent abortion due to primary antiphospholipid syndrome. The control group was treated with acetyl salicylic acid 81 mg oral tablets (low dose aspirin) alone once daily and the study group was treated with low dose aspirin 81 mg oral tablets plus 20 mg isosorbid mononitrate tablets applied vaginally once daily. Treatment in both groups started once pregnancy was confirmed by B-hGC and ultrasound examination and continued till the end of pregnancy. All patients were firmly instructed to adhere to treatment through regular antenatal care followup and drug tablet return

Sponsors

Benha university hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
20 Years to 32 Years
Healthy volunteers
No

Inclusion criteria

pregnant with recurrent abortion due to primary antiphospholipid syndrone

Exclusion criteria

recurrent abortion due to anatomical, endocrine and other systemic diseases

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026