Use of Sildenafil Citrate in Management of Mild Pre-eclampsia
NCT ID: NCT03262961
Last Updated: 2017-08-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE2/PHASE3
Total Enrollment
80 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-09-15
Study Completion Date
2018-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sildenafil Citrate Added to Low Molecular Weight Heparin and Low Dose Aspirin in High-risk Pregnancy
NCT04110444
High Risk Pregnancy
WITHDRAWN
Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses
NCT02362399
Pregnancy Complication
COMPLETED
NA
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
NCT00141310
Pre-eclampsia
TERMINATED
PHASE2
Efficacy of Sildenafil in Preterm Preeclampsia
NCT02782559
Preterm Preeclampsia
WITHDRAWN
PHASE2/PHASE3
A Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction
NCT02590536
Fetal Growth Retardation
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
\- 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 9.1% to 12.5% of all deliveries. The incidence of pre-eclampsia has risen in the developing countries and even in the developed countries as the USA since the 1990s. Among the hypertensive disorders that complicate pregnancy, pre-eclampsia and eclampsia stand as major causes of maternal and perinatal morbidity and mortality worldwide. Nearly one tenth of all maternal deaths in Africa and Asia and one quarter in Latin America are associated with hypertensive diseases in pregnancy, a category that includes pre-eclampsia and the complications that are related to it.
However, the pathogenesis of pre-eclampsia is only partially understood and it is related to disturbances in placentation at the beginning of pregnancy, followed by generalized inflammation and progressive endothelial damage. There are other uncertainties too: the diagnosis, screening and management of pre-eclampsia remain controversial, as does the classification and the degree of its severity.
However, it is generally accepted as published in the different journals and in the WHO recommendations that the onset of a new episode of hypertension during pregnancy (with persistent systolic blood pressure 140 mm Hg and diastolic blood pressure 90 mm Hg or more) with the occurrence of substantial proteinuria (\>0.3 g/24 h or confirmation of proteinuria by semiquantitative urine dipstick analysis with a result of at least 1+) can be used as criteria for identifying pre-eclampsia.
Although pathophysiological changes (e.g. inadequate placentation) exist from very early stages of the pregnancy, hypertension and proteinuria usually become apparent in the second half of pregnancy.
Complications of pre-eclampsia can affect both the mother and the fetus. Acutely, pre-eclampsia can be complicated by eclampsia , the development of HELLP Syndrome , hemorrhagic or ischemic stroke, liver damage and dysfunction, acute kidney injury and Acute Respiratory Distress Syndrome (ARDS).
So early detection of pre-eclampsia and prevention of the occurrence of any of its complications would save the lives of many women and prevent the possible devastating maternal and neonatal outcome of pre-eclampsia, That's why we are concerned in our study with pre-eclampsia, covering the gestational age from 28 - 36 weeks.
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.
Its action is similar to the action of nitric oxide, which is a potent vasodilator, especially for the venules, besides being an inhibitor of platelet aggregation. During pregnancy, nitric oxide is synthesized in in utero-placental tissues and endothelial cells, helping to maintain low vascular resistance in the utero- and fetoplacental circulations. Phosphodiesterase metabolizes cyclic guanosine monophosphate; therefore, phosphodiesterase type 5 inhibition leads to cyclic guanosine monophosphate increase with associated vasodilation, independently of nitric oxide. Therefore, phosphodiesterase type 5 inhibitors have the potential to achieve similar therapeutic goals when compared with nitric oxide.
A potential advantage of phosphodiesterase type 5 inhibitors is that they may overcome the main limitation to nitric oxide use in pregnancy, which is tolerance and headaches. The most studied phosphodiesterase type 5 inhibitor is sildenafil citrate, which has previously shown promising outcomes both in vitro and in animal studies.
That is why we decided to study the role of Sildenafil Citrate in expectant and conservative management of mild pre-eclampsia, as it has shown its ability to be beneficial to both the mother and the fetus through increasing the maternofetal circulation perfusion and achieving a maternal hemodynamic stability and compare it to the current NICE (National Institute for Health and Care Excellence) guidelines that are currently used, that recommends conservative management of mild pre-eclampsia through control of maternal blood pressure and frequent screening of maternal laboratory investigations' abnormalities to detect possible progression to severe pre-eclamptic toxemia.
However, the pathogenesis of pre-eclampsia is only partially understood and it is related to disturbances in placentation at the beginning of pregnancy, followed by generalized inflammation and progressive endothelial damage. There are other uncertainties too: the diagnosis, screening and management of pre-eclampsia remain controversial, as does the classification and the degree of its severity.
However, it is generally accepted as published in the different journals and in the WHO recommendations that the onset of a new episode of hypertension during pregnancy (with persistent systolic blood pressure 140 mm Hg and diastolic blood pressure 90 mm Hg or more) with the occurrence of substantial proteinuria (\>0.3 g/24 h or confirmation of proteinuria by semiquantitative urine dipstick analysis with a result of at least 1+) can be used as criteria for identifying pre-eclampsia.
Although pathophysiological changes (e.g. inadequate placentation) exist from very early stages of the pregnancy, hypertension and proteinuria usually become apparent in the second half of pregnancy.
Complications of pre-eclampsia can affect both the mother and the fetus. Acutely, pre-eclampsia can be complicated by eclampsia , the development of HELLP Syndrome , hemorrhagic or ischemic stroke, liver damage and dysfunction, acute kidney injury and Acute Respiratory Distress Syndrome (ARDS).
So early detection of pre-eclampsia and prevention of the occurrence of any of its complications would save the lives of many women and prevent the possible devastating maternal and neonatal outcome of pre-eclampsia, That's why we are concerned in our study with pre-eclampsia, covering the gestational age from 28 - 36 weeks.
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.
Its action is similar to the action of nitric oxide, which is a potent vasodilator, especially for the venules, besides being an inhibitor of platelet aggregation. During pregnancy, nitric oxide is synthesized in in utero-placental tissues and endothelial cells, helping to maintain low vascular resistance in the utero- and fetoplacental circulations. Phosphodiesterase metabolizes cyclic guanosine monophosphate; therefore, phosphodiesterase type 5 inhibition leads to cyclic guanosine monophosphate increase with associated vasodilation, independently of nitric oxide. Therefore, phosphodiesterase type 5 inhibitors have the potential to achieve similar therapeutic goals when compared with nitric oxide.
A potential advantage of phosphodiesterase type 5 inhibitors is that they may overcome the main limitation to nitric oxide use in pregnancy, which is tolerance and headaches. The most studied phosphodiesterase type 5 inhibitor is sildenafil citrate, which has previously shown promising outcomes both in vitro and in animal studies.
That is why we decided to study the role of Sildenafil Citrate in expectant and conservative management of mild pre-eclampsia, as it has shown its ability to be beneficial to both the mother and the fetus through increasing the maternofetal circulation perfusion and achieving a maternal hemodynamic stability and compare it to the current NICE (National Institute for Health and Care Excellence) guidelines that are currently used, that recommends conservative management of mild pre-eclampsia through control of maternal blood pressure and frequent screening of maternal laboratory investigations' abnormalities to detect possible progression to severe pre-eclamptic toxemia.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Pre-Eclampsia; Mild
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
\- Double blinded, randomized, placebo-controlled trial.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
\- It's a double blinded, randomized, placebo-controlled trial.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group
• 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.
Group Type
ACTIVE_COMPARATOR
Sildenafil 20 MG
Intervention Type
DRUG
Control Group
\- 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.
Group Type
PLACEBO_COMPARATOR
Placebo Oral Tablet
Intervention Type
DRUG
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sildenafil 20 MG
Intervention Type
DRUG
Placebo Oral Tablet
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Sildenafil Citrate 20 mg ( Respatio® 20 mg)
Placebo drug
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
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.
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
35 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fady Nasef Tous Abdallah
Resident of Obstetrics and Gynecology Department - Assiut University
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fady Abdallah
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Hasan Kamel
Role: STUDY_DIRECTOR
Assiut University
Hisham Abou-Taleb
Role: STUDY_DIRECTOR
Assiut University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assiut Univeristy Hospitals
Asyut, , Egypt
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Egypt
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Eiland E, Nzerue C, Faulkner M. Preeclampsia 2012. J Pregnancy. 2012;2012:586578. doi: 10.1155/2012/586578. Epub 2012 Jul 11.
Reference Type
BACKGROUND
El-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.
Reference Type
BACKGROUND
Steegers 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.
Reference Type
BACKGROUND
Khan 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.
Reference Type
BACKGROUND
Campbell 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.
Reference Type
BACKGROUND
Roberts 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.
Reference Type
BACKGROUND
Arulkumaran 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.
Reference Type
BACKGROUND
Mustafa 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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Sibai BM. Magnesium sulfate prophylaxis in preeclampsia: Lessons learned from recent trials. Am J Obstet Gynecol. 2004 Jun;190(6):1520-6. doi: 10.1016/j.ajog.2003.12.057.
Reference Type
BACKGROUND
Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
Reference Type
BACKGROUND
Sibai BM, Mercer BM, Schiff E, Friedman SA. Aggressive versus expectant management of severe preeclampsia at 28 to 32 weeks' gestation: a randomized controlled trial. Am J Obstet Gynecol. 1994 Sep;171(3):818-22. doi: 10.1016/0002-9378(94)90104-x.
Reference Type
BACKGROUND
Haddad B, Deis S, Goffinet F, Paniel BJ, Cabrol D, Siba BM. Maternal and perinatal outcomes during expectant management of 239 severe preeclamptic women between 24 and 33 weeks' gestation. Am J Obstet Gynecol. 2004 Jun;190(6):1590-5; discussion 1595-7. doi: 10.1016/j.ajog.2004.03.050.
Reference Type
BACKGROUND
Manktelow BN, Seaton SE, Field DJ, Draper ES. Population-based estimates of in-unit survival for very preterm infants. Pediatrics. 2013 Feb;131(2):e425-32. doi: 10.1542/peds.2012-2189. Epub 2013 Jan 14.
Reference Type
BACKGROUND
Cauli O, Herraiz S, Pellicer B, Pellicer A, Felipo V. Treatment with sildenafil prevents impairment of learning in rats born to pre-eclamptic mothers. Neuroscience. 2010 Dec 1;171(2):506-12. doi: 10.1016/j.neuroscience.2010.08.065. Epub 2010 Sep 9.
Reference Type
BACKGROUND
Coppage KH, Sun X, Baker RS, Clark KE. Expression of phosphodiesterase 5 in maternal and fetal sheep. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 2):1005-10. doi: 10.1016/j.ajog.2005.05.054.
Reference Type
BACKGROUND
Samangaya RA, Mires G, Shennan A, Skillern L, Howe D, McLeod A, Baker PN. A randomised, double-blinded, placebo-controlled study of the phosphodiesterase type 5 inhibitor sildenafil for the treatment of preeclampsia. Hypertens Pregnancy. 2009 Aug;28(4):369-82. doi: 10.3109/10641950802601278.
Reference Type
BACKGROUND
Trapani A Jr, Goncalves LF, Trapani TF, Franco MJ, Galluzzo RN, Pires MM. Comparison between transdermal nitroglycerin and sildenafil citrate in intrauterine growth restriction: effects on uterine, umbilical and fetal middle cerebral artery pulsatility indices. Ultrasound Obstet Gynecol. 2016 Jul;48(1):61-5. doi: 10.1002/uog.15673.
Reference Type
BACKGROUND
Galie N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D, Fleming T, Parpia T, Burgess G, Branzi A, Grimminger F, Kurzyna M, Simonneau G; Sildenafil Use in Pulmonary Arterial Hypertension (SUPER) Study Group. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 2005 Nov 17;353(20):2148-57. doi: 10.1056/NEJMoa050010.
Reference Type
BACKGROUND
ACOG Practice bulletin no. 134: fetal growth restriction. Obstet Gynecol. 2013 May;121(5):1122-1133. doi: 10.1097/01.AOG.0000429658.85846.f9.
Reference Type
BACKGROUND
Matt H, Nigel J. (2016) "Renal disease in pregnancy" ;Obstet Gynaecol Reprod Med; 26:46-52
Reference Type
BACKGROUND
Dastjerdi MV, Hosseini S, Bayani L. Sildenafil citrate and uteroplacental perfusion in fetal growth restriction. J Res Med Sci. 2012 Jul;17(7):632-6.
Reference Type
RESULT
McKeeman GC, Ardill JE, Caldwell CM, Hunter AJ, McClure N. Soluble vascular endothelial growth factor receptor-1 (sFlt-1) is increased throughout gestation in patients who have preeclampsia develop. Am J Obstet Gynecol. 2004 Oct;191(4):1240-6. doi: 10.1016/j.ajog.2004.03.004.
Reference Type
RESULT
Moncada S, Higgs A. The L-arginine-nitric oxide pathway. N Engl J Med. 1993 Dec 30;329(27):2002-12. doi: 10.1056/NEJM199312303292706. No abstract available.
Reference Type
RESULT
Learmont JG, Poston L. Nitric oxide is involved in flow-induced dilation of isolated human small fetoplacental arteries. Am J Obstet Gynecol. 1996 Feb;174(2):583-8. doi: 10.1016/s0002-9378(96)70432-5.
Reference Type
RESULT
Lees C, Valensise H, Black R, Harrington K, Byiers S, Romanini C, Campbell S. The efficacy and fetal-maternal cardiovascular effects of transdermal glyceryl trinitrate in the prophylaxis of pre-eclampsia and its complications: a randomized double-blind placebo-controlled trial. Ultrasound Obstet Gynecol. 1998 Nov;12(5):334-8. doi: 10.1046/j.1469-0705.1998.12050334.x.
Reference Type
RESULT
Trapani A Jr, Goncalves LF, Pires MM. Transdermal nitroglycerin in patients with severe pre-eclampsia with placental insufficiency: effect on uterine, umbilical and fetal middle cerebral artery resistance indices. Ultrasound Obstet Gynecol. 2011 Oct;38(4):389-94. doi: 10.1002/uog.8983.
Reference Type
RESULT
Wareing M, Myers JE, O'Hara M, Baker PN. Sildenafil citrate (Viagra) enhances vasodilatation in fetal growth restriction. J Clin Endocrinol Metab. 2005 May;90(5):2550-5. doi: 10.1210/jc.2004-1831. Epub 2005 Feb 15.
Reference Type
RESULT
Trapani A Jr, Goncalves LF, Trapani TF, Vieira S, Pires M, Pires MMS. Perinatal and Hemodynamic Evaluation of Sildenafil Citrate for Preeclampsia Treatment: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):253-259. doi: 10.1097/AOG.0000000000001518.
Reference Type
RESULT
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
assiutu252
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction
NCT02678221
UNKNOWN
PHASE2
Sildenafil Effect After Ovulation Induction
NCT02890238
UNKNOWN
PHASE4
Sildenafil Citrate Therapy for Oligohydramnios
NCT02372487
UNKNOWN
NA
Sildenafil Citrate and Intrapartum Fetal Distress
NCT04325243
COMPLETED
PHASE4
Sildenafil Citrate for Treatment of Growth-restricted Fetuses
NCT03177824
UNKNOWN
PHASE3
Intrapartum Sildenafil in Laboring Mothers
NCT06377098
WITHDRAWN
PHASE3
Sildenafil in Sever Intrauterine Growth Retardation
NCT03153215
COMPLETED
NA
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages
NCT01419392
UNKNOWN
PHASE4
Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss
NCT04718233
COMPLETED
PHASE2
The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene
NCT02663830
COMPLETED
PHASE2
Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
NCT03230162
UNKNOWN
PHASE3
Sildenafil and Uteroplacental Perfusion
NCT01107782
UNKNOWN
PHASE2/PHASE3
Viagra for the Treatment of IUGR
NCT00347867
UNKNOWN
PHASE4
Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension
NCT04912726
WITHDRAWN
NA
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
NCT05946681
COMPLETED
Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness
NCT05846906
COMPLETED
PHASE2/PHASE3
Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility
NCT05753098
COMPLETED
PHASE4
Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate in Infertile Women With Thin Endometrium
NCT02710981
COMPLETED
NA
Safety of Sildenafil in Premature Infants
NCT03142568
COMPLETED
PHASE2
Sildenafil Citrate of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development
NCT03044561
UNKNOWN
PHASE4
Effect of Vaginal Sildenafil Citrate on Endometrial Preparation and Outcome in Frozen Thawed Embryo Transfer Cycles
NCT03854175
UNKNOWN
NA
Vardenafil Vs Sildenafil for the Treatment of Pulmonary Hypertension of the Newborn
NCT06860399
COMPLETED
PHASE1/PHASE2
Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
NCT06522854
WITHDRAWN
PHASE3
Vitamin D Versus Sildenafil Citrate in Fetal Growth Restriction
NCT06565728
COMPLETED
PHASE1
Sildenafil Citrate and Recurrent Abortion
NCT03475160
COMPLETED
NA