Clinical trial · Interventional
Use of Sildenafil Citrate in Management of Mild Pre-eclampsia
Use of Sildenafil Citrate in Management of Mild Pre-eclampsia: A Randomized Controlled Trial
NCT03262961CI-TRIAL-00029295unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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 have shown that expectant and conservative management of pre-eclampsia in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has been estimated that for each additional day of pregnancy prolongation between 24 and 32 weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival. * Sildenafil citrate has been used for increasing utero-placental perfusion in cases with intrauterine growth restriction, which makes it a promising drug in management of mild pre-eclampsia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pre-Eclampsia; Mild | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
| Sildenafil 20 MG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention Group
- description
- • The intervention group will be supplied with Sildenafil Citrate (Respatio® 20mg tablets manufactured by Pharma Right Group , Egypt) according to the patient's weight by the rate of (1.5 mg/kg/day) divided into three doses per day ( every 8 hours) till termination of pregnancy.
- interventionNames
- Drug: Sildenafil 20 MG
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- \- The control group will be supplied with a placebo drug that has the same shape, size and color but without the active ingredient and it would also be taken in a similar way. The placebo tablet will be manufactured at the faculty of pharmacy, Assiut University.
- interventionNames
- Drug: Placebo Oral Tablet
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: 1. Uncomplicated mild pre-eclampsia; No clinical or investigatory findings suggestive severe pre-eclamptic toxemia. 2. 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. 3. Singleton viable pregnancy. 4. Age: 18-35 years. Exclusion Criteria: 1. Severe pre-eclamptic toxemia (according to the NICE guidelines (2010): Hypertension in pregnancy: diagnosis and management) 2. Intrauterine growth retardation. 3. Use of medication that could interact with sildenafil citrate such as nitrates erythromycin, ketoconazole, itraconazole, antiretroviral agents and others. 4. Presence of maternal co-morbidity disease as: DM, chronic hypertension, congestive heart failure, chronic kidney disease and SLE. 5. Placenta previa. 6. The patient is using aspirin. 7. 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.
References
Publications (29)
- BACKGROUNDEiland E, Nzerue C, Faulkner M. Preeclampsia 2012. J Pregnancy. 2012;2012:586578. doi: 10.1155/2012/586578. Epub 2012 Jul 11. PMID 22848831
- BACKGROUNDEl-Moselhy, E; Khalifa, H; Amer, S (2011). "Risk Factors and Impacts of Pre-Eclampsia: An Epidemiological Study among Pregnant Mothers in Cairo, Egypt" J Am Sci 7(5): 311-323.
- BACKGROUNDSteegers EA, von Dadelszen P, Duvekot JJ, Pijnenborg R. Pre-eclampsia. Lancet. 2010 Aug 21;376(9741):631-44. doi: 10.1016/S0140-6736(10)60279-6. Epub 2010 Jul 2. PMID 20598363
- BACKGROUNDKhan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9. PMID 16581405
- BACKGROUNDCampbell OM, Graham WJ; Lancet Maternal Survival Series steering group. Strategies for reducing maternal mortality: getting on with what works. Lancet. 2006 Oct 7;368(9543):1284-99. doi: 10.1016/S0140-6736(06)69381-1. PMID 17027735
- BACKGROUNDRoberts JM, Cooper DW. Pathogenesis and genetics of pre-eclampsia. Lancet. 2001 Jan 6;357(9249):53-6. doi: 10.1016/s0140-6736(00)03577-7. PMID 11197372
- BACKGROUNDArulkumaran N, Lightstone L. Severe pre-eclampsia and hypertensive crises. Best Pract Res Clin Obstet Gynaecol. 2013 Dec;27(6):877-84. doi: 10.1016/j.bpobgyn.2013.07.003. Epub 2013 Aug 17. PMID 23962474
- BACKGROUNDMustafa R, Ahmed S, Gupta A, Venuto RC. A comprehensive review of hypertension in pregnancy. J Pregnancy. 2012;2012:105918. doi: 10.1155/2012/105918. Epub 2012 May 23. PMID 22685661
- Report of the National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy. Am J Obstet Gynecol. 2000 Jul;183(1):S1-S22.