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临床试验/ACTRN12616001494426
ACTRN12616001494426已完成不适用

Comparative study between placebo vaginal tablets and the nitric oxide donor isosorbide mononitrate 20 mg tablet applied vaginally for treatment of unexplained recurrent early pregnancy loss

Banha University Hospital0 个研究点目标入组 158 人开始时间: 2016年10月27日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
158

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment

入排标准

年龄范围
18 Years 至 30 Years(—)
性别
Female

入选标准

  • The study included 225 patients with the following inclusion criteria: 1- Nulliparous aged 18-30 years, house-wives and nonsmokers. 2- History of two consecutive failed clinical pregnancies from the same husband during the first trimester and confirmed by ultrasound. 3- Normal levels of lupus anticoagulant and anticardiolipin IgG and IgM on two or more occasions at least 12 weeks apart. 4- Normal uterine cavity and no pelvic pathology diagnosed by 3D/4D ultrasound. Hysterography, Sono-hysterography, hysteroscopy and laparoscopy was done in few suspicious cases. 5- Normal blood glucose and hemoglobin A1c levels. 6- Normal serum TSH, serum prolactin and mid luteal phase serum progesterone levels >10 ng/ml. 7- Cytogenetic study of the parents was done for 14 patients who had the third loss during the study and feature no balanced reciprocal translocations.

排除标准

  • Exclusion criteria include patients with cardiac disease, hypertension, sensitivity to NO donors and cases of interim ectopic or molar pregnancy or blighted ovum.

研究者

发起方
Banha University Hospital

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