The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion

Not Applicable

Completed

• Conditions: Recurrent Spontaneous Abortion; Ultrasound Therapy; Acupuncture; Coagulation
• Interventions: Procedure: acupuncture; Drug: routine aspirin and heparin treatment

• Registration Number: NCT05998421
• Lead Sponsor: Jianmei Xia

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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-07-29
• Status Verified: 2023-08
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-16
• Last Update Submitted: 2023-08-16
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the drug-accompanied-by-acupuncture group (acupuncture group)	routine aspirin and heparin treatment	The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle.
the drug group (control group)	routine aspirin and heparin treatment	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.
the drug-accompanied-by-acupuncture group (acupuncture group)	acupuncture	The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle.

Primary Outcome Measures

Name	Time	Method
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 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 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.
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 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.

Trial Locations

Locations (1)

Jianmei Xia; 🇨🇳 Hangzhou, Zhejiang, China