Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT03262961
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT03262961
Study Brief:
Protocol Section:
NCT03262961