Acupuncture, Coagulation, Recurrent Spontaneous Abortion, Ultrasound Therapy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREacupuncture
The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle. Seirin 0.2-×30-mm acupuncture needles were used. First, needles were inserted into Shenting (GV 24) and bilateral Benshen (G 13) to relieve uneasiness of mind. Then, they were inserted into Chung wan (cv 12), Qihai (CV6), Guan yuan, chung chi (cv 3), bilateral Guiai (S 29) and Zigong (Extra 16) to recuperate energy. Finally, bilateral Tsusanli (st 36), Yinlingch'uan (sp 9) and San yin chiao (sp 6) were used to soothe the liver and tonify the spleen and kidney. Each acupuncture treatment session lasted 30 minutes, with mostly bilateral needle retention over 20-30 minutes for evens techniques.
DRUGroutine aspirin and heparin treatment
The patients accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day.
Sponsors
Jianmei Xia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* acute infection in the abdomen or lower back * planning assisted reproductive technologies (ART) in the next 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of acupuncture on pregnancy outcome in patients with recurrent spontaneous abortion | 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 change of blood indicators related to blood coagulation function after acupuncture1 | 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 effect of acupuncture on blood flow impedance in the uterine arteries before and after each treatment cycle | 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 effect of acupuncture on patients' mental anxiety status before and after each treatment cycle | 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. |
| The change of blood indicators related to blood coagulation function after acupuncture2 | 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 | 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. |
Countries
China
Outcome results
None listed