Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients With Unexplained Recurrent Pregnancy Loss
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 主要终点
- Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients with Unexplained Recurrent Pregnancy Loss
研究概览
简要总结
compare uterine artery blood flow before and after the administration of Isosorbide mononitrate as a nitric oxide donor during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.
详细描述
Recurrent pregnancy loss (RPL) is an important reproductive health issue, because it affects 2%-5% of couples. The incidence of RPL varies widely because of the differences in the definitions and criteria used, as well as the populations characteristics (El Hachem et al., 2017).
The reported incidence of early pregnancy loss depends on the method used to detect pregnancy. An estimated 50% of all conceptions are lost at preclinical stages owing to biochemical loss or implantation failure, further 9-20% of clinically recognized pregnancies are miscarried, mainly during the first trimester (weeks 5-12 of gestation), studies consistently demonstrate a sharp reduction after 12 weeks of gestation to an incidence of ~1% suggesting that most pregnancy losses occur soon after implantation (Dimitriadis et al., 2020).
The Royal College of Obstetricians and Gynecologists defines RPL as three or more consecutive pregnancy losses, The most recent RPL guideline from European Society of Human Reproduction and Embryology states that RPL could be considered after the loss of two or more pregnancies and stresses the importance of the need for further scientific research, including epidemiological studies on the effect of various RPL definitions on diagnosis, prognosis and treatment (ESHRE 2017).
Common established causes include uterine anomalies, antiphospholipid syndrome, hormonal and metabolic disorders, and cytogenetic abnormalities. Other etiologies have been proposed but are still considered controversial, such as chronic endometritis, inherited thrombophilia, luteal phase deficiency, and high sperm DNA fragmentation levels (Yang et al., 2019).
Over the years, evidence-based treatments such as surgical correction of uterine anomalies or aspirin and heparin for antiphospholipid syndrome have improved the outcomes for couples with recurrent pregnancy loss. However, almost half of the cases remain unexplained and are empirically treated using progesterone supplementation, anticoagulation, and/or immunomodulatory treatments. Regardless of the cause, the long-term prognosis of couples with recurrent pregnancy loss is good, and most eventually achieve a healthy live birth. However, multiple pregnancy losses can have a significant psychological toll on affected couples, and many efforts are being made to improve treatments and decrease the time needed to achieve a successful pregnancy (El Hachem et al., 2017).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age: 20-35 years.
- •History of recurrent abortion (two or more successive spontaneous abortions) with :
- •Normal HSG or hysteroscopy
- •Normal serum PRL,
- •Normal thyroid function,
- •Normal HbA1c,
- •Normal pelvic ultrasound
- •Negative tests for antiphospholipid antibody syndrome (ACL, Lupus anticoagulant and anti B2 glycoprotein 1) Non pregnant state. Regular menstrual cycles for the previous three months before the study. No hormonal contraception or intrauterine devices. Not on any vasodilator drugs.
排除标准
- •Age less or more than 20-
- •Nulligravidae or nullipara. Infertile women. Induced abortion. Systemic diseases that might affect the hemodynamic indices as thrombocytopenia and thyrotoxicosis.
- •Cases with uterine anomalies, uterine myomas, polypi and adnexal masses. History of oophorectomy. History of consanguinity. Family history of chromosomal abnormality as Down syndrome and Turner syndrome.
研究组 & 干预措施
Uterine artery Doppler Changes After IMN In Patients with URPL
compare uterine artery blood flow before and after the administration of Isosorbide mononitrate as a nitric oxide donor during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.
干预措施: isosorbide mononitrate (Drug)
Uterine artery Doppler Changes After IMN In Patients with URPL
compare uterine artery blood flow before and after the administration of Isosorbide mononitrate as a nitric oxide donor during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.
干预措施: Placebo (Drug)
Uterine artery Doppler Changes After placebo In Patients with URPL
compare uterine artery blood flow before and after the administration of placebo during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.
干预措施: isosorbide mononitrate (Drug)
Uterine artery Doppler Changes After placebo In Patients with URPL
compare uterine artery blood flow before and after the administration of placebo during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.
干预措施: Placebo (Drug)
结局指标
主要结局
Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients with Unexplained Recurrent Pregnancy Loss
时间窗: baseline
compare uterine artery blood flow before and after the administration of Isosorbide mononitrate as a nitric oxide donor during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.
次要结局
未报告次要终点
研究者
Mostafa Tolba Ahmed
Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients with Unexplained Recurrent Pregnancy Loss
Al-Azhar University
