Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss

NCT04718233 | Completed Phase 2 DMC

• 1 other identifier: sildenafilcitrate89
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with recurrent pregnancy loss are known to have decreased uterine artery blood flow. Nitric oxide plays a major role in increasing uterine blood flow during the luteal phase. This study is done to evaluate the effects of sildenafil on blood flow indices in the patients with recurrent pregnancy loss due to impaired uterine artery blood flow.

Conditions

Recurrent Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

• uterine artery blood flow indices

  uterine artery PI, RI

  3 hours

Study Arms (2)

sildenafil citrate

EXPERIMENTAL

Sildenafil citrate at a dose of 25mg will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours.

Drug: Sildenafil 25Mg Tablet

placebo

PLACEBO COMPARATOR

placebo will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours.

Drug: Placebo Oral Tablet

Interventions

Sildenafil 25Mg Tablet DRUG

Sildenafil citrate at a dose of 25mg will be administered orally in patients with recurrent pregnancy loss

sildenafil citrate

Placebo Oral Tablet DRUG

placebo will be administered orally in patients with recurrent pregnancy loss

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• History of 2 or more unexplained recurrent miscarriage.
• Child bearing period (18-35 years old).
• Non pregnant state.
• Regular menstrual cycles for the previous three months before the study.
• No hormonal contraception or intrauterine device.
• impaired uterine artery blood flow (PI \>2.02) (Mansour et al., 2018).

You may not qualify if:

• Having any possible causes of abortion: anatomical, genetic, endocrinological, infectious, or immunological.
• Autoimmune disorders which may affect blood vessels and their blood flow (systemic lupus).
• Systemic disease that might affect the hemodynamic indices (e.g. thrombocytopenia, thyrotoxicosis … etc.).
• Diagnosed or treated thrombophilia. 5- Any vascular disease (e.g. coronary artery disease). 6- History of oophorectomy. 7- History of consanguinity. 8- Family history of chromosomal abnormalities (e.g. trisomy 21, trisomy 13… etc.).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university maternity hospital

Cairo, 25187, Egypt

Location

MeSH Terms

Interventions

Sildenafil Citrate; Tablets

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; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 22, 2021
• Study Start: September 5, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

EG (1)