Clinical trial NCT05998421: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Recurrent Spontaneous Abortion
Ultrasound Therapy
Coagulation
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 46
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The effect of acupuncture on pregnancy outcome in patients with recurrent spontaneous abortion
timeFrame: average of 1 year
measure: The change of blood indicators related to blood coagulation function after acupuncture1
timeFrame: average of half of a year
measure: The effect of acupuncture on blood flow impedance in the uterine arteries before and after each treatment cycle
timeFrame: average of half of a year
measure: The effect of acupuncture on patients' mental anxiety status before and after each treatment cycle
timeFrame: average of half of a year
measure: The change of blood indicators related to blood coagulation function after acupuncture2
timeFrame: average of half of a year
measure: The change of blood indicators related to blood coagulation function after acupuncture3
timeFrame: average of half of a year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Jianmei Xia
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Jianmei Xia
role: PRINCIPAL_INVESTIGATOR
References: