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

NCT05998421 | Completed

• 1 other identifier: 2023003
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Recurrent Spontaneous Abortion; Ultrasound Therapy; Coagulation

Outcome Measures

Primary Outcomes (6)

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

  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.

  average of 1 year

• The change of blood indicators related to blood coagulation function after acupuncture1

  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.

  average of half of a year

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

  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.

  average of half of a year

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

  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.

  average of half of a year

• The change of blood indicators related to blood coagulation function after acupuncture2

  Changes in blood indicators related to blood coagulation function, such as D-dimer (D-D)were also detected before and after treatment.

  average of half of a year

• The change of blood indicators related to blood coagulation function after acupuncture3

  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.

  average of half of a year

Study Arms (2)

the drug group (control group)

ACTIVE COMPARATOR

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.

Drug: routine aspirin and heparin treatment

the drug-accompanied-by-acupuncture group (acupuncture group)

EXPERIMENTAL

The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle.

Procedure: acupuncture; Drug: routine aspirin and heparin treatment

Interventions

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.

the drug-accompanied-by-acupuncture group (acupuncture group)

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.

the drug group (control group); the drug-accompanied-by-acupuncture group (acupuncture group)

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• acute infection in the abdomen or lower back
• planning assisted reproductive technologies (ART) in the next 3 months

Sponsors & Collaborators

• Jianmei Xia: lead

Study Sites (1)

Jianmei Xia

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Abortion, Spontaneous; Thrombosis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jianmei Xia

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 21, 2023
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: July 29, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)