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Evaluation of blood pressure, blood flow fetal and neonatal outcome with the use of a phosphodiesterase type 5 inhibitor in the treatment of women with preeclampsia

Hemodynamics and perinatal assessment of phosphodiesterase type 5 inhibitors in pregnant women with preeclampsia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8qj4p5
Enrollment
Unknown
Registered
2016-02-26
Start date
2013-06-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pre-eclampsia

Interventions

The cases will be randomized into two groups: Experimental group: 50 adult women with preeclampsia take capsules of sildenafil citrate (50 mg) of 8 and 8 hours until delivery indication. Control group
Drug
D27.505.519.389.735

Sponsors

Universidade Federal de Santa Catarina - UFSC
Lead Sponsor
Universidade Federal de Santa Catarina - UFSC
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Pregnant women between 24-33 weeks. Diagnosis of pregnancy induced hypertension, defined as diastolic blood pressure equal to or greater than 90 mmHg and proteinuria above 0.3 g in 24 hours. Admitted at least 24 hours. Signing an informed consent form

Exclusion criteria

Exclusion criteria: Twin pregnancy. Diabetes. Provided hypertension and other chronic diseases. Serious fetal malformations. Fetal vitality of changes indicating the termination of pregnancy (reverse diastole umbilical artery, abnormal ductus venosus, severe oligoâminio, GMP below 6. Maternal changes indicating the termination of pregnancy (Eclampsia, HEELP syndrome, severe renal impairment). Patient use of magnesium sulfate, erythromycin, ketoconazole, itraconazole, or other antiretroviral drugs that have interaction with sildenafil. Refusal to sign the post informed consent.

Design outcomes

Primary

MeasureTime frame
Assess whether there is improvement in the flow in the uterine arteries, umbilical and middle cerebral with the administration of the phosphodiesterase type 5 inhibitors, by examining Doppler. To detect a change in pulsatividade 0.16 umbilical artery ratio, a sample of 26 patients would be required to achieve a 80% power (alpha 0.05).—

Secondary

MeasureTime frame
Evolution of the mean arterial pressure. Time between randomization and delivery, measured in days. Sample calculated for a significant variation of at least five days. Need for other anti hypertensive. To evaluate the neonatal results. Possible side effects and intolerance to medication.—

Countries

Brazil

Contacts

Public ContactAlberto Trapani

Universidade Federal de Santa Catarina - UFSC

ginecoalberto@yahoo.com.br+55(48)99604268

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 1, 2026