The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion: a Randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The effect of acupuncture on blood flow impedance in the uterine arteries before and after each treatment cycle
研究概览
简要总结
Recurrent spontaneous abortion (RSA) is a common pregnancy complication in women of reproductive age and the cause of RSA remains largely unclear. Acupuncture is widely used in clinical practice to treat infertility and abortion. The role of acupuncture in the treatment of infertility is still unclear. The investigators conducted a randomized, prospective, controlled clinical trial to investigate its potential impact on pregnancy outcome. Herein, the investigators not only evaluated the changes in patients' psychological stress before and after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were also detected.
详细描述
To better illustrate the effectiveness and mechanism of acupuncture in infertility, especially in RSA patients, the investigators conducted a randomized, prospective, controlled clinical trial to investigate its potential impact on pregnancy outcome. Herein, the investigators not only evaluated the changes in patients' psychological stress before and after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were also detected. The investigators hypothesized that acupuncture could promote and improve pregnancy by improving uterine artery blood flow and relieving patients' anxiety symptoms. To our knowledge, it has never been reported before.
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, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •had a previous RSA history;
- •had a normal body mass index (BMI) of 18-25 kg/m2;
- •had no acute infection of the abdomen and low back skin;
- •had no history of liver or kidney disease.
排除标准
- •acute infection in the abdomen or lower back
- •planning assisted reproductive technologies (ART) in the next 3 months
研究组 & 干预措施
the drug group (control group)
The patients in the control group accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day.
干预措施: routine aspirin and heparin treatment (Drug)
the drug-accompanied-by-acupuncture group (acupuncture group)
The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle.
干预措施: acupuncture (Procedure)
the drug-accompanied-by-acupuncture group (acupuncture group)
The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle.
干预措施: routine aspirin and heparin treatment (Drug)
结局指标
主要结局
The effect of acupuncture on blood flow impedance in the uterine arteries before and after each treatment cycle
时间窗: average of half of a year
Patients in both groups were scheduled for vaginal ultrasound in the mid luteal phase to monitor the blood flow impedance in the uterine arteries before and after each treatment cycle, measured as the uterine artery (UA) systolic/diastolic (S/D) blood flow ratio.
The change of blood indicators related to blood coagulation function after acupuncture1
时间窗: average of half of a year
Changes in blood indicators related to blood coagulation function, such as platelet maximum aggregation rate (MAR, inducted by arachidonic acid (AA) and adenosine diphosphate (ADP)), were also detected before and after treatment.
The change of blood indicators related to blood coagulation function after acupuncture2
时间窗: average of half of a year
Changes in blood indicators related to blood coagulation function, such as D-dimer (D-D)were also detected before and after treatment.
The change of blood indicators related to blood coagulation function after acupuncture3
时间窗: average of half of a year
Changes in blood indicators related to blood coagulation function, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), were also detected before and after treatment.
The effect of acupuncture on pregnancy outcome in patients with recurrent spontaneous abortion
时间窗: average of 1 year
The pregnancy outcome of each patient was followed-up. The outcomes of natural pregnancy include normal clinical pregnancy(intrauterine pregnancy and pregnancy week ≥28) and adverse pregnancy. The latter includes biochemical pregnancy, spontaneous abortion and ectopic gestation.
The effect of acupuncture on patients' mental anxiety status before and after each treatment cycle
时间窗: average of half of a year
Generalized anxiety disorder (GAD-7) was used to assess patients' mental anxiety status. Each item has a score of 0-3, totaling 7 items, with a total score of 0-21. The higher the score, the more severe it becomes.
次要结局
未报告次要终点
研究者
Jianmei Xia
Deputy Chief Physician
First People's Hospital of Hangzhou