Sildenafil Citrate Added to Low Molecular Weight Heparin and Low Dose Aspirin in High-risk Pregnancy

NCT04110444 | Withdrawn

• 1 other identifier: SMElbaradie
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Anticoagulant therapy is indicated during pregnancy for the prevention and treatment of venous thromboembolism, systemic embolism in patients with mechanical heart valves and, in combination with aspirin, for the prevention of recurrent pregnancy loss in women with antiphospholipid antibodies Sildenafil citrate increases uterine blood flow and potentiates estrogen-induced vasodilatation. Intravaginal administration of Sildenafil in the success of in vitro fertilization describes no deleterious effects on mother and fetus

Conditions

High Risk Pregnancy

Outcome Measures

Primary Outcomes (1)

• change in abdominal circumference and estimated fetal weight after 2 weeks of therapy

  ultrasound assessment of fetal growth

  two weeks

Secondary Outcomes (1)

• amniotic fluid index 5-15 cm with minimum increase of 2 cm

  two weeks

Study Arms (2)

sildenafile group A

received sildenafil citrate orally 20mg every 8 hours based on previous studies18,21 (Respatio tablet, pharma Egypt group) in addition to low molecular weight heparin daily according to the bodyweight at the booking visit (Clexane 20,40,60 mg, Sanofi eventis company) plus small dose of aspirin 75 mg (Aspocid 75mg tablet, CID pharmaceutical) once daily

Drug: Sildenafil

control group B

received low molecular weight heparin as subcutaneous injection once daily plus low dose aspirin 75mg orally once daily in addition to placebo three times daily prepared by a local pharmacy from a domestic manufacturer

Interventions

Sildenafil DRUG

oral sildenafil t.d.s for high-risk pregnancies

sildenafile group A

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

high-risk pregnant women of gestational age 28-37 weeks women with current preeclampsia, IUGR and oligohydramnios

You may qualify if:

• high-risk pregnant women (women with current preeclampsia, IUGR and oligohydramnios)
• gestational age 28-37 weeks
• no major medical illness contraindicating sildenafil use (cardiovascular disease, sickle cell anaemia, retinopathy, hearing loss, liver diseases)
• willingness to sign informed consent for study randomization

You may not qualify if:

• gestational age less than 28 weeks
• refusal of Doppler studies or sildenafil use
• contraindication or allergy to sildenafil
• those who can't present for monitoring visits or follow medication instructions
• those with major medical illness including cardiovascular disease and diabetes mellitus
• multiple pregnancies
• suspected chromosomal or fetal congenital anomalies (documented by level II ultrasound examination)
• users of any vasodilator agents
• those who had maternal or fetal emergencies necessitating delivery at time of recruitment in the study or with diastolic blood pressure more than 110 mmHg
• BMI is more than 34 that would impede accurate measurement of fetal biometry and Doppler parameters

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

sahar M.Y elbaradie

Al Fayyum, Egypt

Location

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate Professor

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 1, 2019
• Study Start: January 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

EG (1)