Role of Serum Progesterone and Doppler Ultrasound in Prediction of Pregnancy Outcome in Women With Recurrent Unexplained Abortion
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- number of Live births after 28 weeks of gestation
研究概览
简要总结
Recurrent pregnancy loss is classically defined as the occurrence of three or more consecutive pregnancy loss. The American Society of Reproductive Medicine has recently redefined recurrent pregnancy loss as two or more pregnancy losses. A pregnancy loss is defined as a clinically-recognized pregnancy means that the pregnancy has been visualized on an ultrasound or that pregnancy tissue was identified after a pregnancy loss.
详细描述
Spontaneous pregnancy loss is a surprisingly common occurrence. Whereas approximately 15% of all clinically recognized pregnancies result in spontaneous loss, there are many more pregnancies that fail prior to being clinically recognized. Only 30% of all conceptions result in a live birth.
Although no reliable published data have estimated the probability of finding an etiology for recurrent pregnancy loss in a population with 2 versus 3 or more miscarriages, the best available data suggest that the risk of miscarriage in subsequent pregnancies is 30% after 2 losses, compared with 33% after 3 losses among patients without a history of a live birth. This strongly suggests a role for evaluation after just 2 losses in patients with no prior live births. An earlier evaluation may be further indicated if fetal cardiac activity was identified prior to a loss .
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
- None
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
- •pregnant 7-12 weeks documented by pregnancy test &/or ultrasaound.
- •History of at least 2 prior spontaneous abortion before 12 weeks of gestation.
- •Age: 18-35 years
- •Willing and able to give informed consent.
- •Rh +ve patient
- •Viable pregnancy through the detection of fetal pulsations by ultrasound
- •Singleton pregnancy
- •Apparently stable pregnancy (no history of vaginal bleeding in this current pregnancy or signs of sac separation in ultrasound)
排除标准
- •Patients diagnosed to have Anti-phospholipid syndrome or another recognised thrombophilic or autoimmune conditions.
- •Pregnant > 12 weeks.
- •Contraindication to progesterone use.
- •Diabetic patients, have glucose intolerance.
- •Multiple pregnancies.
- •Thyroid disorder
研究组 & 干预措施
progesterone suppositories vaginal group
vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.
干预措施: Progesterone Suppositories Vaginal (Drug)
progesterone suppositories vaginal group
vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.
干预措施: doppler ultrasound (Device)
Dydrogesterone oral tablets group
20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.
干预措施: Dydrogesterone Oral Tablet (Drug)
Dydrogesterone oral tablets group
20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.
干预措施: doppler ultrasound (Device)
结局指标
主要结局
number of Live births after 28 weeks of gestation
时间窗: 28 weeks gestation
Live births that survive and continue beyond 28 weeks of gestation
次要结局
- Number of patients who Tolerable with the treatment(12 weeks)
研究者
GKElsherief
prinicipal investigator
Assiut University