Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss Due to Impaired Uterine Artery Blood Flow
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- uterine artery blood flow indices
研究概览
简要总结
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.
详细描述
Study Setting: The study will be conducted in recurrent pregnancy loss outpatient clinic at Ain shams university maternity hospital.
Study Population: Patients with unexplained recurrent miscarriage attending Ain shams university maternity hospital's outpatient clinic. This study will be conducted on 80 women distributed into 2 groups each is 40 women in fertile age with history of two or more recurrent spontaneous abortions and decreased uterine artery blood flow(PI>2.02(Mansour et al., 2018). First group will be placebo controlled and the second group will be given sildenafil citrate.
Women will be asked to attend during the 21-23 day of the cycle and will be subjected to: History taking and Full clinical examination.
Clinical examination will be done including general, abdominal and pelvic examination.
General examination: including general appearance, weight, height and vital signs Abdominal examination: to assure freedom of any organic clinically detectable pathologic lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •1-Having any possible causes of abortion: anatomical, genetic, endocrinological, infectious, or immunological.
- •2- Autoimmune disorders which may affect blood vessels and their blood flow (systemic lupus).
- •3- Systemic disease that might affect the hemodynamic indices (e.g. thrombocytopenia, thyrotoxicosis ... etc.).
- •4- 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.).
研究组 & 干预措施
sildenafil citrate
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.
干预措施: Sildenafil 25Mg Tablet (Drug)
placebo
placebo will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
uterine artery blood flow indices
时间窗: 3 hours
uterine artery PI, RI
次要结局
未报告次要终点
研究者
Ahmed Abass
lecturer
Ain Shams University