A Randomized, Placebo-controlled, Double-blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The difference in the subsequent livebirth rate among patients with secondary recurrent miscarriage who, during the trial, receive intravenous immunoglobulin or placebo, respectively, without any exclusions (ITT analysis)
研究概览
简要总结
The investigators want to test whether infusions of intravenous immunoglobulin - a blood product known to modify immune responses - in early pregnancy will increase the chance of a subsequent live birth in women with three or more miscarriages after a birth and a total of at least four miscarriages. This will be done in a trial where 82 patients will be randomly allocated to infusions with intravenous immunoglobulin or placebo during pregnancy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •4 or more miscarriages before the end of gestational week 14 in patients with secondary recurrent miscarriages.
- •At least three of these must be consecutive after the previous birth
- •At least two of the miscarriages with the present partner.
排除标准
- •Age below 18 or above 41 years at conception
- •Significant uterine anomalies detected by hysterosalpingography, hysteroscopy or hydrosonography.
- •Significant chromosomal aberrations in the couple
- •Menstrual cycle < 23 or > 35 days
- •Presence of lupus anticoagulant or IgG anticardiolipin concentration >= 40 GPL ku/l or plasma homocystein >= 25 microg./l by repeated measurements at 8 weeks intervals
- •Tests positive for HIV or tests indicating carriage of hepatitis B or C
- •IgA deficiency
- •Allergy to albumin, IvIg or one of the substances added to preserve the drugs.
- •Presence of chronic disease, which necessitate permanent treatment with e.g. corticosteroids , non-steroidal antiinflammatory drugs, anticoagulation, simvastatin or imurel from the start of pregnancy.
- •Less than 2 of the previous pregnancy losses documented by ultrasound or uterine curettage.
- •Present pregnancy a result of donor insemination or egg donation.
- •Planned administration of gestagens or estrogens from the beginning of pregnancy.
- •3 or more previous IVF/ICSI/FER attempts resulting in chemical pregnancy/miscarriage.
- •Previous participation in the trial.
研究组 & 干预措施
IvIg
Repeated infusions of intravenous immunoglobulin in early pregnancy
干预措施: Intravenous immunoglobulin (Drug)
placebo
infusion of human albumin CSL Behring 5%
干预措施: Human albumin (Drug)
结局指标
主要结局
The difference in the subsequent livebirth rate among patients with secondary recurrent miscarriage who, during the trial, receive intravenous immunoglobulin or placebo, respectively, without any exclusions (ITT analysis)
时间窗: August 2008 to June 2011
次要结局
- The difference in the subsequent livebirth rate among women with secondary recurrent miscarriage who receive intravenous immunoglobulin or placebo, respectively, after relevant and predefined exclusions (PP analysis).(August 2008 to June 2011)
研究者
Ole B Christiansen
consultant
Rigshospitalet, Denmark