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NCT Number: NCT05998421

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

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.

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Key information

Conditions

Acupuncture Abortion, Spontaneous Cardiovascular Diseases Coagulation Embolism and Thrombosis Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Recurrent Spontaneous Abortion Thrombosis Ultrasound Therapy Urogenital Diseases Vascular Diseases

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jianmei Xia

Hangzhou, Zhejiang, 310006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

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.

routine aspirin and heparin treatment

Drug

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.

Primary outcomes

  1. The effect of acupuncture on pregnancy outcome in patients with recurrent spontaneous abortion

    Time frame: 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.

  2. The change of blood indicators related to blood coagulation function after acupuncture1

    Time frame: 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.

  3. The effect of acupuncture on blood flow impedance in the uterine arteries before and after each treatment cycle

    Time frame: 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.

  4. The effect of acupuncture on patients' mental anxiety status before and after each treatment cycle

    Time frame: 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.

  5. The change of blood indicators related to blood coagulation function after acupuncture2

    Time frame: 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.

  6. The change of blood indicators related to blood coagulation function after acupuncture3

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jianmei Xia

Other

Registry information

Official study title

The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion: a Randomized Prospective Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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