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

Primary Purpose

Acupuncture, Recurrent Spontaneous Abortion, Ultrasound Therapy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
routine aspirin and heparin treatment
Sponsored by
Jianmei Xia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jianmei Xia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

the drug group (control group)

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

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2023
Last Updated
August 16, 2023
Sponsor
Jianmei Xia
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1. Study Identification

Unique Protocol Identification Number
NCT05998421
Brief Title
The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion
Official Title
The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion: a Randomized Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
July 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jianmei Xia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Recurrent Spontaneous Abortion, Ultrasound Therapy, Coagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the drug group (control group)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
the drug-accompanied-by-acupuncture group (acupuncture group)
Arm Type
Experimental
Arm Description
The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle.
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
routine aspirin and heparin treatment
Intervention Description
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 Outcome Measure Information:
Title
The effect of acupuncture on pregnancy outcome in patients with recurrent spontaneous abortion
Description
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.
Time Frame
average of 1 year
Title
The change of blood indicators related to blood coagulation function after acupuncture1
Description
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.
Time Frame
average of half of a year
Title
The effect of acupuncture on blood flow impedance in the uterine arteries before and after each treatment cycle
Description
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.
Time Frame
average of half of a year
Title
The effect of acupuncture on patients' mental anxiety status before and after each treatment cycle
Description
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.
Time Frame
average of half of a year
Title
The change of blood indicators related to blood coagulation function after acupuncture2
Description
Changes in blood indicators related to blood coagulation function, such as D-dimer (D-D)were also detected before and after treatment.
Time Frame
average of half of a year
Title
The change of blood indicators related to blood coagulation function after acupuncture3
Description
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.
Time Frame
average of half of a year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmei Xia
Organizational Affiliation
First People's Hospital of Hangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jianmei Xia
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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