Status:
UNKNOWN
Use of Sildenafil Citrate in Management of Mild Pre-eclampsia
Lead Sponsor:
Assiut University
Conditions:
Pre-Eclampsia; Mild
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
PHASE3
Brief Summary
* Mild pre-eclampsia represents 75% of cases with pre-eclampsia, possible progression to severe pre-eclampsia makes mild pre-eclampsia a serious problem that requires attention. * Previous studies hav...
Detailed Description
\- Pre-eclampsia affects approximately 2-8% of all pregnancies worldwide. In Egypt, the prevalence of pre-eclampsia is 10.7% in a community based study. While, in hospital based studies it ranged from...
Eligibility Criteria
Inclusion
- Uncomplicated mild pre-eclampsia; No clinical or investigatory findings suggestive severe pre-eclamptic toxemia.
- Gestational age of 28 - 36 weeks by good dates according to ACOG's - committee on obstetric practice - Method for Estimating Due Date (2014) who will receive the study's drug for at least one week before termination.
- Singleton viable pregnancy.
- Age: 18-35 years.
Exclusion
- Severe pre-eclamptic toxemia (according to the NICE guidelines (2010): Hypertension in pregnancy: diagnosis and management)
- Intrauterine growth retardation.
- Use of medication that could interact with sildenafil citrate such as nitrates erythromycin, ketoconazole, itraconazole, antiretroviral agents and others.
- Presence of maternal co-morbidity disease as: DM, chronic hypertension, congestive heart failure, chronic kidney disease and SLE.
- Placenta previa.
- The patient is using aspirin.
- The presence of a contraindication to the use of sildenafil citrate:
- Hypersensitivity to sildenafil citrate or any of the tablet ingredients.
- Patients with severe cardiovascular disease such as established cardiac failure and unstable angina pectoris.
- Previous episode of non-arteritic anterior ischaemic optic neuropathy.
- Severe hepatic impairment.
- Hypotension (blood pressure \<90/50 mmHg).
- Hypertension (blood pressure \>170/110 mmHg).
- Recent history of stroke or myocardial infarction.
- Known hereditary degenerative retinal disorders such as retinitis pigmentosa.
Key Trial Info
Start Date :
September 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03262961
Start Date
September 15 2016
End Date
January 15 2018
Last Update
August 28 2017
Active Locations (1)
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1
Assiut Univeristy Hospitals
Asyut, Egypt, 71111