Sildenafil effect in placental vessels.

Phase 1

Conditions: This is a placebo – controlled longitudinal study to determine whether maternal administration of an unique oral dose of sildenafil citrate (50mg) improves placental flow in first trimester in healthy pregnancies. They are pregnant women before twelve weeks who comes to our hospital for legal medical abortion.
MedDRA version: 20.0Level: SOCClassification code 10036585Term: Pregnancy, puerperium and perinatal conditionsSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
MedDRA version: 20.0Level: HLTClassification code 10036569Term: Pregnancy related circumstancesSystem Organ Class: 100000004869
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2017-001878-42-ES

Lead Sponsor: CONSORCIO HOSPITAL GENERAL UNIVERSITARIO DE VALENCIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 60

Inclusion Criteria

1. Healthy women between 20-40 years old.
2. Confirmed pregnant viability without any obstetric complication.
3. First trimester gestational age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Obstetric risk factors : recurrent miscarriage, previous preeclamsia and hematology disease.
- Current use of vasoactive drugs. ( mainly related to hypertension treatment).
- Toxic substances abuse.
- Threatened abortion symptoms.
- Sildenafil Citrate contraindications, as are described in the prescribing information formulary (
exluding pregnancy).