Pregnancy Outcomes in Women With Unexplained Recurrent Pregnancy Loss Treated With Low Dose Aspirin and Unfractionated Heparin
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- pregnancy loss
研究概览
简要总结
Objective To determine maternal and fetal outcomes in women with Unexplained RPL managed with aspirin or unfractionated heparin (UFH) plus aspirin during pregnancy.
Design: prospective clinical controlled study. Setting: high-risk pregnancy unit- Benha university hospital. Methods: Pregnant women with unexplained recurrent miscarriage attending high-risk pregnancy unit. 200 selected patients with previous unexplained recurrent miscarriage are divided into 2 groups: group A (n = 100) receive low-dose aspirin (81 mg once daily orally) plus heparin (5000 IU) every 12 h with the first positive pregnancy test while group B (n = 100) receive no thing .
Main outcome measures: Maternal outcomes included thromboembolic and haemorrhagic complications and pregnancy-induced hypertension .Prematurity, intrauterine growth restriction and neonatal death were considered as maternal and fetal complications
详细描述
This prospective comparative, controlled clinical study is conducted at Department of Obstetrics and Gynecology, Benha University Hospital, and a private center, from June 2012 . After approval of the study protocol by the Local Ethical Committee and obtaining written fully informed patients' consents. All patients are interviewed about their medical, personal, family, obstetrical and thrombosis history. All patients included in study complain of three or more unexplained consecutive spontaneous abortions.
All patients (n=200) are in good general health without previous history of Diabetes Mellitus or thyroid dysfunction or cardiac disease. Patients with Thrombocytopenia (<100000/ml), bleeding tendencies, ectopic pregnancy, past history of vascular thrombosis ,uterine anomalies and multiple gestation are excluded from the study.
complete blood picture, urine routine examination, blood sugar, blood grouping, Bleeding Time, Clotting Time, Prothrombin Time, Activated Partial Thromboplastin Time, Hepatitis B Surface Ag, Hepatitis C Virus screening are offered to all patients and findings noted as soon as they conceived. All patients are given routine Folic Acid, Iron and Calcium supplementation orally daily during antenatal period (whether conceived spontaneously or with treatment
200 selected patients with previous unexplained recurrent pregnancy loss are divided into 2 groups:Group A (n = 100) are put on Inj. UFH (Cal-heparin) 5000 U subcutaneous twice daily plus Aspirin 81 mg/day (Juspirin) with the first positive pregnancy test, Inj. UFH is given either into anterior abdominal wall or anterior aspect of thigh subcutaneously. While group B (n = 100) receive no thing
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with unexplained recurrent pregnancy loss (RPL)
排除标准
- •previous history of Diabetes Mellitus or thyroid dysfunction or cardiac disease
- •Thrombocytopenia (<100000/ml)
- •bleeding tendencies
- •ectopic pregnancy
- •past history of vascular thrombosis
- •uterine anomalies
- •multiple gestation
研究组 & 干预措施
Group A(heparin group)
Group A (n = 100) are put on Inj. UFH (Cal-heparin) 5000 U subcutaneous twice daily plusAspirin 81 mg/day (Juspirin) with the first positive pregnancy test, Inj. UFH is given either into anterior abdominal wall or anterior aspect of thigh subcutaneously
干预措施: Heparin (Drug)
结局指标
主要结局
pregnancy loss
时间窗: during first 20 weeks of gregnancy
evidence of abortion is assessed clinically by vaginal bleeding and passage of contents of conception through vagina or by ultrasound through detecting missed abortion .
次要结局
- Maternal outcomes(during 40 weeks of pregnancy)
- prematurity(after 20 weeks and before 37 weeks gestation)
- fetal outcome(during last half of pregnancy(last 20 weeks))
研究者
khalid abd aziz mohamed
lecturer of ob/gyn
Benha University