Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- The difference between both groups in live birth
研究概览
简要总结
Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation.
The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard pulsatility index (PI) and resistance index (RI), a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications.
详细描述
Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation.
The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard PI and RI, a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications, e.g., preeclampsia and intrauterine growth restriction (|IUGR).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unexplained recurrent spontaneous abortion.
排除标准
- •Abnormal uterine cavity.
- •Luteal phase insufficiency.
- •Endocrinal disorders, e.g., thyroid diseases, hyperprolactinemia, and Diabetes Mellitus.
- •Antiphospholipid syndrome.
- •Inherited or acquired thrombophilia.
- •Patients had renal, hepatic or cardiovascular diseases, hypertension, history of smoking, treated with vasodilators or sensitive to or developed severe side-effects with Sildenafil Citrate.
研究组 & 干预措施
Sildenafil Citrate
Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
干预措施: Sildenafil Citrate vaginal suppositories (Drug)
Sildenafil Citrate
Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
干预措施: Uterine artery Doppler before treatment (Procedure)
Sildenafil Citrate
Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
干预措施: Uterine artery Doppler after treatment (Procedure)
Placebo
Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
干预措施: Placebo vaginal suppositories (Drug)
Placebo
Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
干预措施: Uterine artery Doppler before treatment (Procedure)
Placebo
Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
干预措施: Uterine artery Doppler after treatment (Procedure)
结局指标
主要结局
The difference between both groups in live birth
时间窗: Through study completion, an average of 9 months.
Live birth is defined as an ongoing pregnancy past to the 20th week of gestation
次要结局
- Uterine artery PI at cycle day 21-23 preceding pregnancy(At cycle day 21-23 preceding pregnancy)
- Uterine artery RI at cycle day 21-23 preceding pregnancy(At cycle day 21-23 preceding pregnancy)
- Uterine artery PI at the twelfth week of gestation(At the twelfth week of gestation.)
- Uterine artery RI at the twelfth week of gestation(At the twelfth week of gestation.)
研究者
Ahmed Walid Anwar Murad
Assistant Professor, Department of Obstetrics and Gynecology
Benha University